| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition Assessed by Virtual Histology in Patients With ST-Segment Elevation Acute Myocardial Infarction (VIRHISTAMI) [NCT01058915] | | 87 participants (Actual) | Interventional | 2007-11-30 | Completed |
| [NCT01153334] | Phase 4 | 125 participants (Actual) | Interventional | 2010-08-02 | Completed |
| A Phase I, 2-panel, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Transporter Substrates, Digoxin and Rosuvastatin [NCT01288742] | Phase 1 | 33 participants (Actual) | Interventional | 2011-01-31 | Completed |
| Protective Effect of Rosuvastatin and Antiplatelet Therapy On Contrast-induced Nephropathy and Myocardial Damage in Patients With Acute Coronary Syndrome Undergoing Coronary Intervention; PRATO-ACS Trial [NCT01185938] | Phase 4 | 500 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis [NCT04883840] | Phase 2/Phase 3 | 220 participants (Anticipated) | Interventional | 2020-10-22 | Recruiting |
| Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach [NCT03772262] | Early Phase 1 | 16 participants (Actual) | Interventional | 2018-04-05 | Completed |
| A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia [NCT00090298] | Phase 3 | 2,815 participants (Actual) | Interventional | 2004-04-30 | Completed |
| A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reacti [NCT00239681] | Phase 3 | 17,802 participants (Actual) | Interventional | 2003-02-28 | Terminated(stopped due to See detailed description for reason.) |
| A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of Leritrelvir With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin in Healthy Participants [NCT06031454] | Phase 1 | 56 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
| A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants [NCT05954624] | Phase 1 | 48 participants (Anticipated) | Interventional | 2023-07-10 | Recruiting |
| A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients [NCT03949374] | Phase 4 | 126 participants (Actual) | Interventional | 2015-10-23 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia [NCT03510884] | Phase 3 | 153 participants (Actual) | Interventional | 2018-05-31 | Completed |
| Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on pLatelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual Antiplatelet Therapy [NCT01567774] | Phase 4 | 100 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
| A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan in Patients With Primary Hypercholesterolemia and Essential Hypertension [NCT03872232] | Phase 3 | 180 participants (Actual) | Interventional | 2019-02-26 | Completed |
| A Randomised, Double-blind, Placebo-controlled, Event Driven, Phase III Study of Rosuvastatin 20 mg Once Daily in the Long Term Prevention of Recurrent Venous Thromboembolism in Patients With Deep Vein Thrombosis or Pulmonary Embolism [NCT01164540] | Phase 3 | 3,000 participants (Anticipated) | Interventional | 2011-02-28 | Withdrawn(stopped due to Due to discussion regarding the design of the study.) |
| A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers. [NCT03690778] | Phase 1 | 42 participants (Actual) | Interventional | 2018-10-04 | Completed |
| A Multicenter, Randomized, Open-label, Parallel-group Usability Study of the Commercial 1 mL Alirocumab Auto-injector Device (AI) and the New 2 mL Auto-injector Device (SYDNEY) in High or Very High Cardiovascular Risk Patients With Hypercholesterolemia No [NCT03415178] | Phase 3 | 69 participants (Actual) | Interventional | 2018-03-29 | Completed |
| Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function [NCT01223625] | Phase 4 | 87 participants (Actual) | Interventional | 2007-11-30 | Completed |
| High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading. [NCT01228227] | Phase 3 | 310 participants (Anticipated) | Interventional | 2010-10-31 | Completed |
| A Single-center, Open-label, Three-period, Fixed-sequence Design Study to Investigate the Effect of Daridorexant on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Male Subjects [NCT05480475] | Phase 1 | 24 participants (Actual) | Interventional | 2022-09-03 | Completed |
| Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin [NCT01146483] | Phase 1 | 16 participants (Actual) | Interventional | 2010-04-30 | Completed |
| A Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus Erythematosus [NCT01170585] | Phase 2 | 33 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Primary Prevention of MACE With Standard and Intensive Statin Treatment in Hypercholesterolemia Patients With Concomitant Diabetes and Hypertension [NCT01173939] | | 10,000 participants (Anticipated) | Interventional | 2010-07-31 | Terminated(stopped due to With recommendation from IDMC, Steering Committee terminated this trial due to ethical concerns raised by J-ART study.) |
| A Phase 1, Open-label, Non-Randomized Study to Assess the Effect of DZD9008 on the Pharmacokinetics of the Cocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients With EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer [NCT05926180] | Phase 1 | 31 participants (Anticipated) | Interventional | 2023-07-31 | Recruiting |
| An Investigator-Sponsored,Double Blind,Placebo-controlled,Randomised,Multi-centre Study to Assess the Effects of Very Early Use of Rosuvastatin in Preventing Recurrence of Ischemic Stroke [NCT01364220] | Phase 3 | 318 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to Slow enrollment) |
| Comparative Evaluation of Locally Delivered 1% Metformin and 1.2% Rosuvastatin Gel in Treatment of Intrabony Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial [NCT03204058] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2016-02-10 | Completed |
| A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholester [NCT02445352] | Phase 3 | 379 participants (Actual) | Interventional | 2014-07-31 | Completed |
| An Open-label, Fixed-sequence, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Multiple Oral Doses of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects [NCT02397538] | Phase 1 | 50 participants (Actual) | Interventional | 2015-02-28 | Completed |
| An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Adult Volunteers [NCT03707899] | Phase 1 | 49 participants (Actual) | Interventional | 2018-12-13 | Completed |
| MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes; Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI [NCT01382472] | Phase 4 | 25 participants (Actual) | Interventional | 2011-09-30 | Completed |
| A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants [NCT06160414] | Phase 1 | 20 participants (Anticipated) | Interventional | 2023-12-13 | Not yet recruiting |
| A 26-week, Single Center, Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Evaluate the Effect of Rosuvastatin on Visceral Adipose Tissue in Male Patients With Abdominal Obesity [NCT01068626] | Phase 3 | 54 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT [NCT03657758] | Phase 4 | 75 participants (Anticipated) | Interventional | 2018-09-17 | Not yet recruiting |
| An Open-label, Fixed Sequence, Two-period Study to Evaluate the Effects of Repeated Doses of DS-8500a on the Pharmacokinetics of Rosuvastatin in Healthy Subjects. [NCT03699774] | Phase 1 | 24 participants (Actual) | Interventional | 2015-05-12 | Completed |
| A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercho [NCT02984982] | Phase 4 | 206 participants (Actual) | Interventional | 2016-11-15 | Completed |
| Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume Evaluated by Multi-slice Spiral CT in Patients With Stable Coronary Heart Disease and Hyperlipidemia [NCT01382277] | Phase 4 | 600 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects [NCT03753477] | Phase 1 | 64 participants (Actual) | Interventional | 2017-12-22 | Completed |
| Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia [NCT00871351] | Phase 4 | 125 participants (Actual) | Interventional | 2009-02-01 | Completed |
| A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia [NCT03009487] | Phase 3 | 265 participants (Actual) | Interventional | 2017-01-31 | Completed |
| A Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia [NCT05184179] | | 7,000 participants (Anticipated) | Observational | 2019-12-01 | Enrolling by invitation |
| An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers [NCT02079506] | Phase 1 | 40 participants (Actual) | Interventional | 2014-02-28 | Completed |
| A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia [NCT02087540] | Phase 3 | 310 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects [NCT02127320] | Phase 1 | 24 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia [NCT03566316] | Phase 3 | 134 participants (Actual) | Interventional | 2015-11-24 | Completed |
| A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the Two Different Products Containing 10 mg Film Coated Tablet After Oral Administration to 38 Healthy Adult Volunteers Under Fasting Conditions [NCT05197517] | Phase 1 | 38 participants (Actual) | Interventional | 2020-09-21 | Completed |
| Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3) [NCT01378715] | Phase 3 | 400 participants (Anticipated) | Interventional | 2010-06-30 | Recruiting |
| Pharmacodynamic Comparison of Rosuvastatin Versus Atorvastatin on Platelet Reactivity in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With New P2Y12 Inhibitors [NCT02030054] | Phase 4 | 150 participants (Anticipated) | Interventional | 2015-01-31 | Not yet recruiting |
| Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima Media Thickness and Its Relation to Plaque Components of the Coronary Arteries in Patients With ST-Segment Elevation Acute Myocardial Infarction [NCT01203982] | Phase 4 | 87 participants (Actual) | Interventional | 2007-11-30 | Completed |
| An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CJ-30060 in Healthy Subjects [NCT03757390] | Phase 1 | 52 participants (Anticipated) | Interventional | 2018-11-09 | Recruiting |
| The Study of Rosuvastatin for Reduction of Postoperative Paroxysmal Atrial Fibrillation in Patient Undergoing Radiofrequency Catheter Ablation [NCT02502110] | Phase 4 | 346 participants (Anticipated) | Interventional | 2015-08-31 | Not yet recruiting |
| A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects [NCT03339752] | Phase 1 | 20 participants (Actual) | Interventional | 2017-10-30 | Completed |
| A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Rosuvastatin and Ezetimibe and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia [NCT03288038] | Phase 3 | 382 participants (Actual) | Interventional | 2014-10-13 | Completed |
| Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure [NCT03255044] | Phase 4 | 85 participants (Actual) | Interventional | 2017-06-15 | Completed |
| A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer [NCT04094519] | Phase 1 | 24 participants (Actual) | Interventional | 2020-01-27 | Completed |
| A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg or Placebo When Co-administered With Statins in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension [NCT00532311] | Phase 3 | 411 participants (Actual) | Interventional | 2007-07-31 | Terminated(stopped due to Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents) |
| A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS [NCT02284503] | Phase 4 | 1,350 participants (Anticipated) | Interventional | 2014-11-30 | Not yet recruiting |
| A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers [NCT03187496] | Phase 1 | 24 participants (Actual) | Interventional | 2017-05-11 | Completed |
| The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus [NCT02418884] | Phase 4 | 122 participants (Anticipated) | Interventional | 2015-04-30 | Not yet recruiting |
| A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers [NCT03116516] | Phase 1 | 62 participants (Actual) | Interventional | 2017-04-21 | Completed |
| Different Doses Rosuvastatin Effect on Telomere-telomerase System in Acute Coronary Syndrome Patients After Percutaneous Coronary INtervention: RETAIN Study [NCT02299245] | Phase 4 | 400 participants (Anticipated) | Interventional | 2014-10-31 | Active, not recruiting |
| Effect of LY3314814 on the Pharmacokinetics of Rosuvastatin in Caucasian Healthy Subjects [NCT03019549] | Phase 1 | 42 participants (Actual) | Interventional | 2017-01-12 | Completed |
| Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study [NCT03677297] | Phase 4 | 10 participants (Actual) | Interventional | 2016-01-28 | Completed |
| Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome [NCT04056169] | Phase 4 | 50 participants (Actual) | Interventional | 2017-06-29 | Completed |
| A Randomized, Prospective, Open Label, Active Control, Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease [NCT03434613] | Phase 4 | 64 participants (Actual) | Interventional | 2018-05-14 | Completed |
| A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conv [NCT02476006] | Phase 3 | 998 participants (Actual) | Interventional | 2015-06-23 | Completed |
| A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin Versus Switch [NCT00862251] | Phase 3 | 808 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis [NCT04833764] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
| Comparison of Effects of Atorvastatin Versus Rosuvastatin Treatment on Cardiac Function and Inflammation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: A Randomised, Double Blind Clinical Study [NCT05072054] | Phase 4 | 80 participants (Anticipated) | Interventional | 2019-10-16 | Recruiting |
| Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118] | | 1,600 participants (Anticipated) | Observational | 2018-10-04 | Recruiting |
| The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients [NCT02234492] | Phase 4 | 35 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin [NCT02234882] | Phase 1 | 50 participants (Actual) | Interventional | 2014-09-05 | Completed |
| [NCT02280590] | Phase 4 | 223 participants (Actual) | Interventional | 2014-09-30 | Completed |
| A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia [NCT02126358] | Phase 3 | 290 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia [NCT04491682] | Phase 2/Phase 3 | 36 participants (Actual) | Interventional | 2020-09-01 | Completed |
| Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil [NCT05285085] | | 2,133,900 participants (Actual) | Observational | 2021-11-19 | Completed |
| A Multicenter Prospective Randomized-controlled Interventional Study to Evaluate the Effect of High Dose Rosuvastatin Versus High Dose Rosuvastatin and Ezetimibe in Acute Ischemic Stroke Patients [NCT05884502] | Phase 4 | 330 participants (Anticipated) | Interventional | 2022-09-01 | Recruiting |
| An Open-label, Single-centre Randomized Study Evaluating the Effect of Treatment With Rosuvastatin 5/20mg on Atherosclerotic Disease as Measured by High-Resolution Contrast Enhanced Magnetic Resonance Imaging in Patients With Coronary Artery Disease and H [NCT02305862] | | 150 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
| Rosuvastatin Use in Order to Induce Preeclampsia Resolution in Severe Preeclampsia Cases up to 48 Hours Following Delivery [NCT02314286] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2014-12-31 | Not yet recruiting |
| A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipi [NCT03536598] | Phase 3 | 203 participants (Actual) | Interventional | 2016-10-14 | Completed |
| A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers [NCT03532854] | Phase 1 | 42 participants (Actual) | Interventional | 2018-05-28 | Completed |
| The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial) [NCT02232360] | Phase 4 | 106 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
| A Phase III, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy [NCT02748057] | Phase 3 | 135 participants (Actual) | Interventional | 2016-05-18 | Completed |
| A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects [NCT02060019] | Phase 1 | 57 participants (Actual) | Interventional | 2014-03-31 | Completed |
| A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers [NCT02233218] | Phase 1 | 60 participants (Actual) | Interventional | 2014-07-31 | Completed |
| Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin [NCT03037372] | Phase 3 | 320 participants (Anticipated) | Interventional | 2017-06-01 | Not yet recruiting |
| A 12-Week, Randomized, Open-Label, Multicenter Study Exploring Low-Density Lipoprotein Cholesterol Lowering Efficacy and Safety of Rosuvastatin 20 mg/Day Compared to10 mg/Day in Chinese Patients With Acute Coronary Syndromes [NCT02077257] | Phase 4 | 1,060 participants (Anticipated) | Interventional | 2014-03-31 | Recruiting |
| An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Evaluate the Relative Bioavailability of One Amlodipine 10mg Tablet and Rosuvastatin 20mg Tablet to Two Fixed Dose Combination Tablet Formulations of Amlodipine (10mg [NCT02075619] | Phase 1 | 24 participants (Actual) | Interventional | 2014-03-24 | Completed |
| A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Concomitant Administration of BMS-986020 on the Single-dose Pharmacokinetics of Rosuvastatin in Healthy Subjects [NCT02101125] | Phase 1 | 26 participants (Actual) | Interventional | 2014-03-31 | Completed |
| A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of CTL0801 and CTL0802 Compared to Coadministration in Healthy Adult Volunteers. [NCT05002244] | Phase 1 | 37 participants (Actual) | Interventional | 2021-07-23 | Completed |
| Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging [NCT02114697] | Phase 4 | 9 participants (Actual) | Interventional | 2014-04-30 | Terminated(stopped due to The study was stopped when the original principal investigator moved to a new institution.) |
| A Randomized, Open-label, Single-dose, 2-Way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the Effect of Food on the Pharmacokinetics [NCT02125227] | Phase 1 | 56 participants (Actual) | Interventional | 2014-04-30 | Completed |
| A Prospective, Randomized Trial to Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement [NCT03521700] | Phase 2/Phase 3 | 150 participants (Actual) | Interventional | 2013-06-01 | Completed |
| A Phase I, Single-center, Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects. [NCT01138072] | Phase 1 | 14 participants (Actual) | Interventional | 2010-06-30 | Completed |
| A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia [NCT01763866] | Phase 3 | 2,067 participants (Actual) | Interventional | 2013-01-15 | Completed |
| A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers [NCT02205190] | Phase 1 | 81 participants (Actual) | Interventional | 2014-07-31 | Completed |
| Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study [NCT05832229] | Phase 2 | 256 participants (Anticipated) | Interventional | 2023-10-11 | Recruiting |
| Relative Bioavailability of a Single Oral Dose of Digoxin, Furosemide, Metformin, and Rosuvastatin Given Alone and All Together as a Cocktail, and Investigation of the Effect of Increased Doses of Metformin or Furosemide on Relative Bioavailability of the [NCT02231931] | Phase 1 | 24 participants (Actual) | Interventional | 2014-09-01 | Completed |
| Effects of High-dose StAtin Versus Low-dose Statin Plus Ezetimibe on Statin-Associated Muscle Symptoms & on Reaching Target LDL-C Levels Among Elderly Patients With Atherosclerotic Cardiovascular Disease [NCT04826354] | Phase 4 | 582 participants (Actual) | Interventional | 2021-08-11 | Completed |
| A Phase I, Open-Label, Two-Part Study of the Effect of Multiple-Dose Evobrutinib on Transporter Substrates Digoxin, Metformin, Rosuvastatin, and Sumatriptan Pharmacokinetics in Healthy Participants [NCT05064488] | Phase 1 | 40 participants (Actual) | Interventional | 2021-10-04 | Completed |
| A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers [NCT02289430] | Phase 1 | 59 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine [NCT05850091] | Phase 4 | 200 participants (Anticipated) | Interventional | 2023-11-30 | Recruiting |
| Stroke Imaging Package Study of Intracranial Atherosclerosis [NCT03719820] | | 550 participants (Anticipated) | Observational [Patient Registry] | 2018-11-14 | Recruiting |
| A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants [NCT04608344] | Phase 1 | 27 participants (Actual) | Interventional | 2020-11-04 | Completed |
| A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of RO4917838 on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers [NCT01183585] | Phase 1 | 18 participants (Actual) | Interventional | 2010-08-31 | Completed |
| A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin [NCT03715101] | Phase 1 | 20 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration [NCT01218347] | Phase 4 | 34 participants (Anticipated) | Interventional | 2010-10-31 | Completed |
| A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-04965842 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS [NCT03806101] | Phase 1 | 12 participants (Actual) | Interventional | 2019-01-23 | Completed |
| A Single-center, Open-label, Single-sequence, 2-part Study to Investigate the Effect of 75 mg Macitentan Once Daily at Steady State on the Pharmacokinetics of Riociguat, Sildenafil, Rosuvastatin and Tadalafil in Healthy Male Subjects [NCT04211272] | Phase 1 | 47 participants (Actual) | Interventional | 2020-01-14 | Completed |
| A Study to Assess the Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin Administered as Microdoses in Subjects With Varying Degrees of Renal Insufficiency in the Presence and Absence of Rifampin [NCT03311841] | Phase 1 | 32 participants (Actual) | Interventional | 2018-03-01 | Completed |
| A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuv [NCT03395470] | Phase 1 | 60 participants (Actual) | Interventional | 2017-08-21 | Completed |
| AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline [NCT03903029] | | 242 participants (Actual) | Observational [Patient Registry] | 2014-10-10 | Active, not recruiting |
| A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l [NCT00462748] | Phase 3 | 786 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Use of High Potency Statins and Rates of Admission for Acute Kidney Injury: Multicenter, Retrospective Observational Analysis of Administrative Databases [NCT02518516] | | 2,067,639 participants (Actual) | Observational | 2011-01-31 | Completed |
| [NCT00728780] | Phase 1 | 32 participants (Actual) | Interventional | 2008-08-31 | Completed |
| An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerabillity of CJ-30060 in Healthy Male Subjects [NCT03639493] | Phase 1 | 52 participants (Actual) | Interventional | 2018-04-06 | Completed |
| A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements [NCT05828303] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-07-28 | Recruiting |
| An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia [NCT03510715] | Phase 3 | 18 participants (Actual) | Interventional | 2018-08-31 | Completed |
| Propranolol, Carvedilol and Rosuvastatin in the Prevention of Recurrent Variceal Haemorrhage in Patients With Cirrhotic Portal Hypertension [NCT03720067] | Phase 2/Phase 3 | 80 participants (Anticipated) | Interventional | 2019-01-25 | Recruiting |
| Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia [NCT03784703] | Phase 4 | 160 participants (Actual) | Interventional | 2018-01-01 | Completed |
| A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer [NCT01299038] | Phase 2 | 20 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1358894 in Healthy Male Subjects (Open, Single-dose, Fixed Sequence, Two-period Crossover Design in Each Trial Part) [NCT04099732] | Phase 1 | 26 participants (Actual) | Interventional | 2019-10-07 | Completed |
| KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen [NCT05373277] | Phase 1 | 10 participants (Anticipated) | Interventional | 2022-05-11 | Recruiting |
| A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Study of the Effects of HRS5091 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin and Rosuvastatin in Healthy Volunteers [NCT05273775] | Phase 1 | 22 participants (Actual) | Interventional | 2022-04-29 | Completed |
| A 6-Week, Randomized,Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects. [NCT00654225] | Phase 3 | 2,340 participants (Anticipated) | Interventional | 2002-10-31 | Completed |
| ZD4522 Long Term Extension Trial [NCT00654303] | Phase 3 | 3,500 participants (Anticipated) | Interventional | 1999-08-31 | Completed |
| A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia. [NCT00654537] | Phase 3 | 5,625 participants (Anticipated) | Interventional | 2001-04-30 | Completed |
| The Impact of Intensive Rosuvastatin Therapy on Cerebral Hemodynamics in Patients With Atherosclerotic Intracranial Arterial Stenosis Evaluated by Computed Tomography Perfusion (CTP) [NCT02594800] | Phase 4 | 50 participants (Actual) | Interventional | 2015-12-21 | Completed |
| Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients [NCT02561845] | | 0 participants (Actual) | Observational | 2015-10-31 | Withdrawn |
| A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease [NCT00680017] | Phase 3 | 280 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1323495 in Healthy Male Subjects (Open, Single-dose, Randomised, Two-period Crossover Design in Each Trial Part) [NCT04257032] | Phase 1 | 28 participants (Actual) | Interventional | 2020-02-13 | Completed |
| A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS [NCT05594615] | Phase 1 | 24 participants (Actual) | Interventional | 2022-10-06 | Completed |
| Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial [NCT04472611] | Phase 3 | 250 participants (Actual) | Interventional | 2020-10-30 | Completed |
| STAT (STatins and Aspirin in Trauma) Trial: A Phase II, Pragmatic, Prospective, Randomized, Double-blind, Adaptive Clinical Trial Examining the Efficacy of Statins and Aspirin in the Reduction of Acute Lung Injury and Venous Thromboembolism in Patients Wi [NCT02901067] | Phase 2 | 43 participants (Actual) | Interventional | 2017-02-03 | Terminated(stopped due to COVID-19 pandemic and high proportion of patients meeting exclusion criteria.) |
| Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study [NCT05660135] | | 4,000 participants (Anticipated) | Observational | 2022-06-20 | Recruiting |
| A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar [NCT05411887] | | 3,000 participants (Anticipated) | Observational | 2022-06-20 | Recruiting |
| [NCT00854503] | Phase 3 | 30 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial [NCT02800902] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2015-05-31 | Completed |
| A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate Efficacy and Safety of Ezetimibe/Rosuvastatin Combination Tablets and Candesartan Cilexetil/Amlodipine Besylate Combination Tablets [NCT03847506] | Phase 4 | 127 participants (Actual) | Interventional | 2018-07-05 | Completed |
| Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty - The REMEDY Study [NCT02205775] | Phase 3 | 280 participants (Actual) | Interventional | 2010-05-31 | Terminated(stopped due to difficult recruitment) |
| A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers [NCT02387619] | Phase 1 | 41 participants (Actual) | Interventional | 2015-02-28 | Completed |
| An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers [NCT02186483] | Phase 1 | 24 participants (Actual) | Interventional | 2014-08-31 | Completed |
| Higher Potency Statins and the Risk of New Diabetes: Multicentre, Observational Study of Administrative Databases [NCT02518503] | | 136,966 participants (Actual) | Observational | 2012-07-31 | Completed |
| Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct [NCT04504851] | Phase 2 | 154 participants (Anticipated) | Interventional | 2020-08-12 | Not yet recruiting |
| A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia [NCT03571087] | Phase 3 | 374 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Effect of Rosuvastatin on Prognosis of Clinical Response in Acute Ischemic Stroke Patients [NCT02484027] | Phase 4 | 456 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting |
| [NCT02483871] | Phase 1 | 0 participants (Actual) | Interventional | 2015-10-31 | Withdrawn(stopped due to Enrollment did not meet anticipated goals. Eligibility was a challenge.) |
| A Phase 1, Open Label, Randomized, Two-way Crossover Study to Evaluate the Effect of Multiple Doses of Fidaxomicin on the Single Dose Pharmacokinetics of Rosuvastatin in Healthy Male Subjects [NCT02083627] | Phase 1 | 25 participants (Actual) | Interventional | 2013-02-28 | Completed |
| A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between GP681 and Rosuvastatin/Digoxin/Itraconazole/Oseltamivir in Chinese Healthy Volunteers [NCT05789342] | Phase 1 | 54 participants (Actual) | Interventional | 2023-02-15 | Completed |
| An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers [NCT02089399] | Phase 1 | 32 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin [NCT02104843] | Phase 1 | 18 participants (Actual) | Interventional | 2014-04-30 | Completed |
| EARly Prevention of aTHeroma Progression [NCT02105623] | Phase 4 | 111 participants (Actual) | Interventional | 2014-06-30 | Terminated(stopped due to Slow enrollement, Low Follow-up rate) |
| Intensive Statin Treatment in Acute Ischemic Stroke Patients With INtracranial Atherosclerosis - High-Resolution Magnetic Resonance Imaging Study (STAMINA-MRI Study) [NCT02458755] | Phase 4 | 80 participants (Anticipated) | Interventional | 2012-02-29 | Recruiting |
| An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers [NCT02140489] | Phase 1 | 30 participants (Anticipated) | Interventional | 2014-02-28 | Recruiting |
| A Randomized, Double-blind, Active-controlled, Multicenter Phase3 Trial to Evaluate the Efficacy and Safety of Co-administrated Temisartan/Amlodipine and Rosuvastatin in Subjects With Hypertension and Hyperlipidemia [NCT03067688] | Phase 3 | 202 participants (Actual) | Interventional | 2017-04-11 | Completed |
| Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial [NCT03192579] | Phase 4 | 50 participants (Actual) | Interventional | 2013-07-26 | Completed |
| A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects [NCT02089061] | Phase 1 | 26 participants (Actual) | Interventional | 2014-03-31 | Completed |
| An Open-label Phase 1 Study to Evaluate the Effects of Dabrafenib (GSK2118436) on the Single Dose Pharmacokinetics of an OATP1B1/1B3 Substrate and of a CYP3A4 Substrate in Subjects With BRAF V600 Mutation Positive Tumors [NCT02082665] | Phase 1 | 6 participants (Actual) | Interventional | 2015-02-19 | Completed |
| The Effects of Single-Dose Rifampin on the Pharmacokinetics of Rosuvastatin in Healthy White and Asian Volunteers [NCT02106767] | Phase 1 | 16 participants (Actual) | Interventional | 2014-11-30 | Completed |
| A Phase I, Multi-center, Non-randomized, Open Label, Drug-drug-interaction Study to Determine the Effect of Multiple Doses of Regorafenib (BAY 73-4506) on the Pharmacokinetics of Probe Substrates of Transport Proteins P-gp (Digoxin; Group A) and BCRP (Ros [NCT02106845] | Phase 1 | 42 participants (Actual) | Interventional | 2014-04-22 | Completed |
| 1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial. [NCT03043196] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2015-06-30 | Completed |
| Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides [NCT02117453] | Phase 3 | 121 participants (Actual) | Interventional | 2014-10-27 | Completed |
| [NCT02251847] | Phase 3 | 400 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
| Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria [NCT03550859] | Phase 4 | 374 participants (Anticipated) | Interventional | 2018-06-05 | Recruiting |
| Ezetimibe/Simvastatin and Rosuvastatin for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy: a Randomized, Double Blinded, Placebo Controlled Clinical Trial [NCT02129231] | Phase 2 | 74 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Open-Label, Fixed-Sequence Study in Solid Tumor Subjects to Investigate the Pharmacokinetic Interaction Between Apatinib and Transporter Substrates Rosuvastatin and Metformin. [NCT04428086] | Phase 1 | 19 participants (Actual) | Interventional | 2020-07-27 | Completed |
| Clinical and Biochemical Study of the Effects of Rosuvastatin, Vitamin E, and N-Acetyl Cysteine on Patients With Non-alcoholic Steatohepatitis: a Randomized Controlled Trial [NCT06105060] | Early Phase 1 | 160 participants (Anticipated) | Interventional | 2023-12-17 | Not yet recruiting |
| Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes [NCT02185963] | Phase 4 | 50 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia [NCT00463606] | Phase 3 | 760 participants (Actual) | Interventional | 2007-04-30 | Completed |
| [NCT00719693] | Phase 1 | 115 participants (Actual) | Interventional | 2008-07-31 | Completed |
| A Phase IV, 6-week, Randomised, Double-blind, Multicentre, Parallel Group, Comparative Study to Evaluate the Efficacy of Rosuvastatin 5mg and Atorvastatin 10mg in UK Asian Subjects With Primary Hypercholesterolaemia [NCT00427960] | Phase 4 | 55 participants (Actual) | Interventional | 2006-12-31 | Terminated(stopped due to Due to inadequate recruitment) |
| An Open-label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Cytochrome P450 Probe Drugs in Healthy Adult Subjects [NCT00964106] | Phase 1 | 87 participants (Actual) | Interventional | 2009-08-26 | Completed |
| The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial [NCT00984932] | Phase 3 | 40 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury [NCT00987974] | Phase 4 | 48 participants (Anticipated) | Interventional | 2009-09-30 | Completed |
| A Phase I, Open Label, Parallel Group, Single and Multiple Dose Study in Taiwanese Subjects Identified as CYP2C19 Poor Metabolizers or Extensive Metabolizers Receiving 20 Milligrams of Rosuvastatin Calcium [NCT00766025] | Phase 1 | 50 participants (Anticipated) | Interventional | 2008-09-30 | Completed |
| Effect of High-Dose and Low-Dose Statin for Coronary Plaque Modification [NCT00997880] | Phase 4 | 312 participants (Actual) | Interventional | 2010-04-30 | Completed |
| A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia [NCT05889143] | | 15,000 participants (Anticipated) | Observational | 2023-05-24 | Recruiting |
| Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial [NCT01033955] | Phase 2 | 8 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to H1N1 pandemic concluded in early 2010) |
| A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects [NCT01101568] | Phase 1 | 28 participants (Actual) | Interventional | 2010-04-14 | Completed |
| Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome [NCT05658692] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2022-10-01 | Recruiting |
| DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers [NCT02814500] | Phase 1 | 36 participants (Anticipated) | Interventional | 2016-07-31 | Not yet recruiting |
| An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants [NCT05787002] | Phase 1 | 16 participants (Actual) | Interventional | 2023-03-09 | Completed |
| Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study) [NCT03532139] | Phase 2 | 24 participants (Actual) | Interventional | 2018-07-25 | Active, not recruiting |
| A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R208 (Candesartan Cilexetil and Rosuvastatin Calcium Fixed Dose Combinations) in Comparison to Each Component Administered Alone in Healthy Male Volunteers [NCT02707224] | Phase 1 | 40 participants (Actual) | Interventional | 2015-01-31 | Completed |
| A Pivotal, Open-label, Balanced, Randomised, Two-treatment, Two-sequence, Two-period, Two-way Crossover, Single Oral Dose Bioequivalence Study of Rosuvastatin/ Verisfield 20 mg Film-coated Tablets Versus Crestor/ AstraZeneca 20 mg Film-coated Tablets in H [NCT02767310] | Phase 1 | 49 participants (Actual) | Interventional | 2016-05-31 | Completed |
| [NCT02749994] | Phase 3 | 396 participants (Actual) | Interventional | 2016-04-30 | Completed |
| A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk [NCT00653445] | Phase 3 | 0 participants | Interventional | 2004-06-30 | Completed |
| The Effects of Darunavir Plus Ritonavir on the Pharmacokinetics and Pharmacodynamics of Rosuvastatin [NCT00885495] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2009-01-31 | Completed |
| A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin [NCT02685462] | Phase 1 | 36 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Statins and 90-day Functional Efficiency and Survival in Patients With Spontaneous Intracerebral Hemorrhage [NCT06094244] | | 153 participants (Actual) | Interventional | 2017-03-17 | Completed |
| A Two-cohort, Two-part, Phase 1, Multicenter, Open-label, Fixed-sequence, Drug-Drug Interaction and QTc Assessments of Sitravatinib Followed by Combination Treatment With Nivolumab in Patients With Advanced Solid Malignancies [NCT04887194] | Phase 1 | 40 participants (Actual) | Interventional | 2021-03-26 | Completed |
| A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects [NCT04008186] | Phase 1 | 61 participants (Actual) | Interventional | 2019-06-14 | Completed |
| A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers [NCT02665832] | Phase 1 | 58 participants (Anticipated) | Interventional | 2016-01-31 | Not yet recruiting |
| [NCT00972829] | Phase 4 | 30 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting |
| A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN). [NCT02737319] | Phase 4 | 493 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Statins for Venous Event Reduction in Patients With Venous Thromboembolism [NCT04319627] | Phase 3 | 2,700 participants (Anticipated) | Interventional | 2021-02-10 | Recruiting |
| A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTORâ„¢) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD [NCT00525824] | Phase 3 | 1,743 participants (Actual) | Interventional | 2007-08-31 | Completed |
| A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects [NCT06081166] | Phase 1 | 74 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia [NCT01010516] | Phase 4 | 120 participants (Anticipated) | Interventional | 2009-10-31 | Recruiting |
| Rosuvastatin for Prevention of Deep Vein Thrombosis in Patients Undergoing Total Knee Replacement Arthroplasty: STOP DVT - A Prospective Randomized Controlled Trial [NCT01021488] | Phase 4 | 180 participants (Anticipated) | Interventional | 2009-10-31 | Recruiting |
| Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria [NCT00296374] | Phase 2 | 353 participants (Actual) | Interventional | 2006-02-28 | Completed |
| A Multicenter, Randomized, Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome [NCT00965315] | | 0 participants | Expanded Access | | Available |
| The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris [NCT01325818] | Phase 4 | 150 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| Statin Therapy as a Protective Technique for Potential Cardiovascular Event Occurrences Among Breast Cancer Patients Undergoing Chemotherapy Treatment [NCT01051401] | Phase 1 | 5 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to slow accrual) |
| [NCT02166814] | Phase 3 | 140 participants (Actual) | Interventional | 2014-08-31 | Completed |
| [NCT01011127] | | 0 participants | Observational | 2009-12-31 | Completed |
| The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers [NCT01469416] | Phase 1 | 10 participants (Actual) | Interventional | 2012-03-31 | Completed |
| [NCT02675309] | Phase 1 | 28 participants (Actual) | Interventional | 2016-02-29 | Completed |
| A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers [NCT02671097] | Phase 1 | 30 participants (Actual) | Interventional | 2016-02-29 | Completed |
| A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia [NCT00654173] | Phase 3 | 4,444 participants (Actual) | Interventional | 2002-06-30 | Completed |
| An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia [NCT00654407] | Phase 3 | 4,875 participants (Anticipated) | Interventional | 2001-11-30 | Completed |
| A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With [NCT00654485] | Phase 3 | 940 participants (Anticipated) | Interventional | 2002-05-31 | Completed |
| Efficacy and Safety of Rosuvastatin in the Prevention of Arterial and Venous Vascular Events and Mortality After Hip Fracture: A Multicenter Randomised, Double-blinded, Placebo Controlled Trial. [NCT01494090] | Phase 3 | 36 participants (Actual) | Interventional | 2011-08-31 | Terminated(stopped due to Decision of the Steering Committee. Recruitment more difficult and slower than expected.) |
| [NCT02561884] | Phase 1 | 58 participants (Actual) | Interventional | 2015-10-31 | Enrolling by invitation |
| An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease. [NCT00657527] | Phase 3 | 280 participants (Anticipated) | Interventional | 2001-12-31 | Completed |
| Effects of Rosuvastatin on the, in Vivo, Kinetic of VLDL apoB, IDL apoB, LDL apoB and HDL apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients [NCT00658463] | Phase 4 | 8 participants (Actual) | Interventional | 2006-01-31 | Completed |
| INdians Followed for INtensive Lipid Lowering Treatment and Its safetY: To Assess The Safety And Effectiveness Of Ezetimibe Co-Administered With Any Statin Compared To Doubling Of Current Statin Daily Dose In South Asian Canadians [NCT00664469] | Phase 3 | 64 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to Poor enrollment) |
| [NCT00681395] | Phase 1 | 64 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes [NCT02586129] | Phase 3 | 249 participants (Actual) | Interventional | 2015-11-04 | Completed |
| A Phase 1, 2-Panel, Open-Label, Fixed-Sequence Study in Healthy Adult Subjects to Investigate the Pharmacokinetic Interaction Between JNJ-54861911 and Transporter Substrates Rosuvastatin and Metformin [NCT02611518] | Phase 1 | 32 participants (Actual) | Interventional | 2016-04-05 | Completed |
| Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT)Combined With Intravascular Ultrasound (IVUS) [NCT01023607] | Phase 4 | 120 participants (Actual) | Interventional | 2009-12-31 | Completed |
| Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient [NCT00786136] | Phase 4 | 2,998 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Quality of Life and Metabolic Alterations in Patients With Statin-Associated Myopathy [NCT00850460] | Phase 4 | 14 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to Investigator left institution and no PI has been found to continue the study) |
| Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes [NCT02612714] | Phase 4 | 151 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol. [NCT00800800] | Phase 3 | 378 participants (Anticipated) | Interventional | 2002-11-30 | Completed |
| A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers [NCT02608242] | Phase 1 | 123 participants (Actual) | Interventional | 2015-11-30 | Terminated(stopped due to sponsor decision) |
| Effect of Rosuvastatin on Endothelial Function in Patients With Diabetes and Glaucoma [NCT00913562] | Phase 4 | 0 participants (Actual) | Interventional | 2009-06-30 | Withdrawn |
| [NCT00808678] | Phase 1 | 90 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Open Label, Fixed Sequences, One-way Cross-over Study to Determine the Effects of Multiple Doses BAY1817080 (150 mg) on the Pharmacokinetics of a 5 mg Dose Rosuvastatin in Healthy Participants [NCT04252300] | Phase 1 | 14 participants (Actual) | Interventional | 2020-03-02 | Completed |
| A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in Hispanic Subjects. [NCT00653965] | Phase 3 | 3,000 participants (Anticipated) | Interventional | 2003-05-31 | Completed |
| Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial [NCT02645227] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2015-01-31 | Completed |
| An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid [NCT02859129] | Phase 1 | 114 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN) [NCT00620542] | Phase 3 | 2,333 participants (Actual) | Interventional | 2008-01-31 | Completed |
| [NCT02569814] | Phase 1 | 100 participants (Actual) | Interventional | 2015-09-30 | Completed |
| The Effect of Usual Dose Rosuvastatin Plue Ezetimibe Versus High-dose Rosuvastatin on Coronary Atherosclerotic Plaque: A Randomized Controlled Trial [NCT03169985] | Phase 4 | 280 participants (Anticipated) | Interventional | 2017-07-12 | Recruiting |
| A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia [NCT04161001] | Phase 3 | 237 participants (Anticipated) | Interventional | 2019-11-20 | Recruiting |
| Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-Dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease [NCT00693589] | Phase 2 | 36 participants (Actual) | Interventional | 2005-01-31 | Completed |
| The Impact of the Time of Drug Administration on the Effectiveness of Combined Treatment of Hypercholesterolemia With ROSuvastatin and EZEtimibe (ROSEZE) - A Single-center, Crossover, Open-label Study [NCT02772640] | Phase 4 | 83 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia [NCT00934258] | | 0 participants | Expanded Access | | Available |
| Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects [NCT00930670] | Phase 4 | 320 participants (Actual) | Interventional | 2009-06-30 | Completed |
| Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice. [NCT04862962] | | 120 participants (Actual) | Observational | 2021-09-30 | Completed |
| Effect of Rosuvastatin on Sever Preeclampsia Induced Inflammatory Response [NCT04303806] | Phase 2 | 80 participants (Anticipated) | Interventional | 2020-10-31 | Not yet recruiting |
| Is Augmentation of PORH by Rosuvastatin Adenosine-receptor Mediated? [NCT00851175] | Phase 4 | 8 participants (Anticipated) | Interventional | 2009-03-31 | Completed |
| Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial [NCT00923676] | Phase 4 | 300 participants (Actual) | Interventional | 2008-04-30 | Active, not recruiting |
| A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastati [NCT02670070] | Phase 1 | 37 participants (Actual) | Interventional | 2016-03-31 | Enrolling by invitation |
| Efficacy of Fixed-dose Combination of Valsartan + Rosuvastatin Versus Their Isolated Components for Hypertension and Dyslipidemia. [NCT02662894] | Phase 3 | 0 participants (Actual) | Interventional | 2019-10-31 | Withdrawn(stopped due to Sponsor decision) |
| Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level [NCT00866229] | Phase 4 | 140 participants (Anticipated) | Interventional | 2008-04-30 | Recruiting |
| Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis [NCT00555230] | Phase 2 | 150 participants (Actual) | Interventional | 2007-07-31 | Completed |
| European Society of Hypertension and Chinese Hypertension League Stroke in Hypertension Optimal Treatment Trial [NCT01563731] | Phase 4 | 200 participants (Actual) | Interventional | 2013-04-30 | Completed |
| Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases [NCT01389388] | | 114 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Effect of Pioglitazone on Insulin Resistance, Progression of Atherosclerosis and Clinical Course of Coronary Heart Disease [NCT03011775] | Phase 4 | 43 participants (Actual) | Interventional | 2012-11-30 | Completed |
| An Open Label, Sequential, Single Cohort, Repeat Dose Study to Investigate the Potential Interaction of GSK2190915 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects. [NCT01411111] | Phase 1 | 28 participants (Actual) | Interventional | 2011-01-06 | Completed |
| A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery [NCT01425398] | Phase 3 | 170 participants (Actual) | Interventional | 2011-11-30 | Completed |
| A Phase I, Dose Finding Study of the Combination of High-dose Statin Agent (Rosuvastatin) With Erlotinib in Patients With Advanced Solid Malignancies, With a Focus on Squamous Cell Carcinomas and NSCLC. [NCT00966472] | Phase 1 | 24 participants (Actual) | Interventional | 2009-03-31 | Completed |
| A Year 2, Long-Term, Open-Label, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia [NCT00491530] | Phase 3 | 310 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia [NCT04074551] | Phase 3 | 145 participants (Actual) | Interventional | 2019-07-16 | Completed |
| A 104-week, Open-label, Single-group Study: Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH) [NCT00885872] | Phase 4 | 60 participants (Anticipated) | Interventional | 2009-03-31 | Recruiting |
| A Phase IIIb, Efficacy, and Safety Study of Rosuvastatin in Children 10-17 Years of Age With Heterozygous Familial Hypercholesterolemia: a 12-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study With a 40-week, Open-label, Follow-up [NCT00355615] | Phase 3 | 173 participants (Actual) | Interventional | 2006-07-31 | Completed |
| An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event [NCT00132717] | Phase 3 | 450 participants (Actual) | Interventional | 2005-01-01 | Completed |
| A Phase 1, Open-label Study in Healthy Adult Subjects to Evaluate Effects of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-99677 and the Effects of CC-99677 on the Pharmacokinetics of Digoxin, Metformin, Methotrexate, Midazolam, R [NCT04268394] | Phase 1 | 48 participants (Actual) | Interventional | 2020-03-13 | Completed |
| A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors [NCT02626234] | Phase 1 | 32 participants (Actual) | Interventional | 2015-12-08 | Completed |
| Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals [NCT00673582] | Phase 4 | 250 participants (Anticipated) | Interventional | 2008-04-30 | Terminated(stopped due to Sponsor has withdrawn the funding) |
| A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiova [NCT00783042] | Early Phase 1 | 80 participants (Anticipated) | Interventional | 2008-10-31 | Completed |
| A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants [NCT05176314] | Phase 1 | 34 participants (Actual) | Interventional | 2022-01-10 | Completed |
| A Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Max [NCT00683618] | Phase 3 | 934 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Effect of Rosuvastatin on Immunological Markers After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2 [NCT00990028] | Phase 1/Phase 2 | 40 participants (Actual) | Interventional | 2009-08-31 | Completed |
| [NCT02789475] | Phase 1 | 38 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting |
| A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tab [NCT02963116] | Phase 1 | 12 participants (Actual) | Interventional | 2016-12-20 | Completed |
| "An Open-Label, Randomized, Parallel-Group, Multicenter Study to Compare the Efficacy and Safety of Switching to Rosuvastatin 10 mg Daily Versus Atorvastatin 10 mg Daily With Ezetimibe 10 mg Daily Versus Doubling the Dose of Atorvastatin to 20 mg Daily in [NCT00651378] | Phase 4 | 87 participants (Actual) | Interventional | 2004-09-01 | Terminated(stopped due to Slow enrollment [HIGH SCREEN FAILURE RATE]) |
| A PHASE 1, 2-PERIOD FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS [NCT04092595] | Phase 1 | 12 participants (Actual) | Interventional | 2019-09-26 | Completed |
| High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER) [NCT02841774] | Phase 2 | 10 participants (Actual) | Interventional | 2016-11-30 | Completed |
| The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy) [NCT02767401] | Phase 4 | 200 participants (Actual) | Interventional | 2015-09-15 | Completed |
| A Phase I, Randomized, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LD [NCT05384262] | Phase 1 | 197 participants (Anticipated) | Interventional | 2022-05-18 | Recruiting |
| A Single-Blind, Placebo-Controlled, Randomized First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Dose Escalation of GSK932121 in Healthy Adult Subjects [NCT00811356] | Phase 1 | 12 participants (Actual) | Interventional | 2008-12-11 | Terminated(stopped due to safety issues (toxicity)) |
| A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects [NCT03245229] | Phase 1 | 20 participants (Actual) | Interventional | 2017-08-10 | Completed |
| Open-label Biomarker Study of Rosuvastatin (Crestor) for the Treatment of Patients With Friedreich Ataxia [NCT02705547] | Early Phase 1 | 12 participants (Actual) | Interventional | 2016-05-31 | Completed |
| A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer [NCT01870466] | Phase 1 | 63 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Impact of Early High-dose Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury in Unselected Patients With Non- ST Elevation Acute Coronary Syndromes Scheduled for Early Invasive Strategy. [NCT01870804] | Phase 4 | 760 participants (Actual) | Interventional | 2013-05-31 | Completed |
| 12-week, Open-label, Multi-center, Prospective Study Evaluating the Effect of Individualizing Starting Doses of Rosuvastatin According to Baseline LDL (Low Density Lipoprotein)-Cholesterol Levels on Achieving Cholesterol Targets in Type 2 Diabetic Patient [NCT00747149] | Phase 4 | 598 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging in Two Years [NCT02041117] | Phase 4 | 162 participants (Actual) | Interventional | 2014-02-24 | Completed |
| Microvascular Resistance in Women With Chest Pain and no or Minimal Coronary Artery Disease [NCT01582165] | Phase 4 | 66 participants (Actual) | Interventional | 2012-06-30 | Completed |
| A Randomized, Open-label, Multiple-dose, Two-arm, One-sequence • Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration Telmisartan/S-amlodipine and Rosuvastatin in Healthy Volunteers [NCT02047175] | Phase 1 | 64 participants (Actual) | Interventional | 2014-02-28 | Completed |
| Effect of Rosuvastatin Therapy on HDL2 Level and Antiatherosclerotic Reverse Cholesterol Transport Process in Chinses CAD Patients With Hyperlipidemia [NCT02593487] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting |
| [NCT00826358] | Phase 1 | 90 participants (Actual) | Interventional | 2008-11-30 | Completed |
| A Randomised, Double-blind, Placebo-controlled, Mono-centre, Explorative Phase II Trial to Study the Effects of Rosuvastatin on Basal Production and Release of Nitric Oxide From the Renal Vasculature in Patients With Hypercholesterolemia. [NCT00160745] | Phase 2 | 46 participants | Interventional | | Completed |
| Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event [NCT03988101] | Phase 4 | 100 participants (Anticipated) | Interventional | 2019-09-19 | Recruiting |
| ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis [NCT01007279] | Phase 3 | 160 participants (Anticipated) | Interventional | 2010-03-31 | Completed |
| A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin [NCT03970798] | Phase 1 | 50 participants (Actual) | Interventional | 2019-05-22 | Completed |
| A 2-year, Open-label, Randomized Study to Evaluate the Efficacy of Rosuvastatin Dosing Adjustment by LDL-C Level Compared to That of 5mg Maintenance Dose in Chinese Patients With Carotid Atherosclerotic Plaques [NCT02532309] | Phase 4 | 308 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| A 6-week, Randomised, Open-label, Parallel Group, Multi-centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Metabolic Syndrome Subjects With Raised LDL-C [NCT00395486] | Phase 4 | 258 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial [NCT03993236] | Phase 4 | 584 participants (Anticipated) | Interventional | 2019-09-09 | Recruiting |
| A Three-Part Phase 1 Study to Evaluate the Potential Drug-Drug Interactions Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel-Ethinyl Estradiol-Containing Oral Contraceptives, and Carbamazepine in Healthy Adult Participants [NCT06071442] | Phase 1 | 60 participants (Anticipated) | Interventional | 2023-10-09 | Recruiting |
| A Fixed Sequence, Open-label Study to Assess the Effect of Multiple Doses of AZD5462 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Probe), Rosuvastatin (OATP1B1/3, BCRP Probe), and Digoxin (P-gp Probe) in Healthy Participants [NCT05395117] | Phase 1 | 32 participants (Actual) | Interventional | 2022-06-30 | Completed |
| A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography [NCT00329160] | Phase 4 | 214 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Randomised, Double-blind, 52-wk, Parallel-grp Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Non-diabetic Patients With Moderate Proteinuria [NCT00296400] | Phase 2 | 237 participants (Actual) | Interventional | 2006-02-28 | Completed |
| A Phase III, Randomized, Active Comparator-controlled, Clinical Trial to Study the Efficacy and Safety of MK-0653H in Japanese Patients With Hypercholesterolemia. [NCT02741245] | Phase 3 | 321 participants (Actual) | Interventional | 2016-06-09 | Completed |
| Pilot Study of the Impact of Rosuvastatin Administration on Residual Chronic Immune Activation Under Antiretroviral Therapy: CESAR (Crestor En Sus Des AntiRétroviraux) [NCT01874743] | Phase 2 | 40 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
| A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Investigate the Safety and Efficacy Between YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia [NCT01914432] | Phase 3 | 210 participants (Actual) | Interventional | 2013-11-30 | Completed |
| A Randomized, Open-label, Single Dose Crossover Study to Compare the Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg in Health [NCT01918358] | Phase 1 | 60 participants (Actual) | Interventional | 2012-12-31 | Completed |
| A Randomized, Open Label, Multiple Dose, Cross-over, Phase I Trial to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers [NCT01918709] | Phase 1 | 30 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults [NCT01935674] | Phase 4 | 21 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular [NCT00479713] | Phase 3 | 618 participants (Actual) | Interventional | 2007-02-01 | Completed |
| [NCT01936805] | Phase 3 | 299 participants (Actual) | Interventional | 2008-01-31 | Completed |
| An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Rosuvastatin Ca Tab 40 mg [Torrent,India] Versus Crestor 40 mg Tab [ AstraZeneca Pharmaceuticals LP, USA] in Healthy Subjects-Fed Condition. [NCT02962323] | Phase 1 | 48 participants (Actual) | Interventional | 2009-11-30 | Completed |
| The Effect of Rosuvastatin on Aortic Stiffness in Hemodialysis Patients in the AURORA Study [NCT00240279] | Phase 3 | 10 participants | Interventional | 2003-01-31 | Completed |
| An 18-week, Randomized, Multicenter, Phase 3b, Double-blind, Crossover Study, Followed by an 18-week Open-Label Period to Evaluate the Efficacy & Safety of the Lipid-Regulating Agents, Rosuvastatin & Pravastatin in the Treatment of Subjects With Dysbetali [NCT00214604] | Phase 3 | 30 participants | Interventional | 2005-02-28 | Completed |
| : An Open-Label, Randomised, Multi-Centre, Phase IIIb/IV, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb Hypercholesterolaemia (DISCOVERY) [NCT00241488] | Phase 3 | 1,362 participants (Anticipated) | Interventional | 2003-06-30 | Completed |
| Supplements, Placebo, or Rosuvastatin Study [NCT04846231] | Phase 2 | 203 participants (Actual) | Interventional | 2021-04-23 | Completed |
| A Multi-center, Open-lable, Fixed-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of SHR3680 With Pgoxin (P-gp Substrates), Rosuvastatin Calcium (BCRP and OATP1B1/1B3 Substrates) and Metformin Hydrochloride (MATE1 [NCT04621669] | Phase 1 | 18 participants (Anticipated) | Interventional | 2020-11-19 | Not yet recruiting |
| A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184 [NCT01953835] | Phase 1 | 37 participants (Actual) | Interventional | 2013-10-04 | Completed |
| Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery [NCT01955759] | Early Phase 1 | 260 participants (Anticipated) | Interventional | 2013-12-31 | Not yet recruiting |
| A Phase 1, Open-Label, Single-Sequence Drug Interaction Study to Evaluate the Effect of Multiple-Dose ASP015K on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects [NCT01959399] | Phase 1 | 24 participants (Actual) | Interventional | 2013-05-31 | Completed |
| Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention [NCT01968577] | Phase 4 | 528 participants (Anticipated) | Interventional | 2011-03-31 | Recruiting |
| A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of TA-8995 in Patients With Mild Dyslipidaemia, Alone and In Combination With Statin Therapy [NCT01970215] | Phase 2 | 364 participants (Actual) | Interventional | 2013-08-31 | Completed |
| [NCT01971606] | Phase 4 | 234 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Use of Rosuvastatin to Achieve Lipid Targets in African American Subjects With Cerebrovascular Disease [NCT01975194] | Phase 4 | 20 participants (Actual) | Interventional | 2012-01-31 | Terminated(stopped due to loss of research personnel) |
| A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers [NCT01975961] | Phase 1 | 185 participants (Actual) | Interventional | 2013-07-31 | Completed |
| A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia [NCT01982461] | | 40 participants (Anticipated) | Interventional | 2013-11-30 | Recruiting |
| Randomized, Open, Cross-over, Single Dose Study to Evaluate the PK, Safety/Tolerability of BCWP_C003 Compared to Coadministration of Rosuvastatin and Metformin SR, and the Food Effect on the PK of BCWP_C003 in Healthy Volunteers [NCT01992211] | Phase 1 | 35 participants (Actual) | Interventional | 2016-12-15 | Completed |
| A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer [NCT01992601] | Phase 1 | 48 participants (Actual) | Interventional | 2012-11-30 | Completed |
| A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg, 100 mg or Placebo When Coadministered With Rosuvastatin 10 mg or 20 mg in Subjects With Primary Hypercholesterolemia [NCT00249912] | Phase 3 | 415 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers [NCT01178853] | Phase 4 | 48 participants (Actual) | Interventional | 2010-07-31 | Completed |
| The Effects of Statin and Angiotensin-converting Enzyme Inhibitor on Coronary Flow Reserve, indEx of Microcirculatory Resistance, and Symptoms in Patients With Spontaneous Coronary Artery Dissection (SAFER-SCAD) Study [NCT02008786] | Phase 4 | 40 participants (Anticipated) | Interventional | 2014-06-30 | Recruiting |
| An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers [NCT02011633] | Phase 1 | 72 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Phase III, 6-Month Self-selection and Actual Use Study for Rx-to-OTC Switch of Rosuvastatin 5 mg Once-daily in Combination With a Web App [NCT04964544] | Phase 3 | 1,189 participants (Actual) | Interventional | 2021-07-08 | Completed |
| An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers [NCT02026817] | Phase 1 | 36 participants (Actual) | Interventional | 2013-12-31 | Completed |
| A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers [NCT02029625] | Phase 1 | 41 participants (Actual) | Interventional | 2014-02-28 | Completed |
| INvestigation of the Gut microbiomE and STatin Response (INGEST) [NCT04098003] | Phase 4 | 62 participants (Actual) | Interventional | 2020-02-06 | Active, not recruiting |
| Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention : A Prospective, Multicenter [NCT06186037] | Phase 4 | 6,356 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| A Double-blind, Double Dummy, Phase IV, Randomized, Multicenter, Parallel Group, Placebo Controlled Trial to Evaluate the Effect of Rosuvastatin on Triglycerides Levels in Mexican Hypertriglyceridemic Patients [NCT00473655] | Phase 4 | 334 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment [NCT00585143] | Phase 1 | 37 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing Percutaneous Coronary Intervention [NCT01646307] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting |
| Identification and Validation of Biomarkers for Breast Cancer Resistance Protein [NCT04542382] | Phase 1 | 20 participants (Anticipated) | Interventional | 2022-02-01 | Active, not recruiting |
| The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2) [NCT03127631] | | 6,000 participants (Anticipated) | Interventional | 2015-10-21 | Recruiting |
| A PHASE 1, RANDOMIZED, FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF NIRMATRELVIR (PF-07321332)/RITONAVIR ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS [NCT05898672] | Phase 1 | 12 participants (Actual) | Interventional | 2023-06-09 | Completed |
| An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetic [NCT05615012] | Phase 1 | 76 participants (Anticipated) | Interventional | 2022-11-11 | Recruiting |
| A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan in Healthy Male Volunteer [NCT01609907] | Phase 1 | 30 participants (Actual) | Interventional | 2011-11-30 | Completed |
| [NCT04328064] | | 56 participants (Actual) | Interventional | 2010-05-31 | Completed |
| An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (Aged From 6 to Less Than 18 Years) With Familial Hypercholesterolaemia [NCT01078675] | Phase 3 | 315 participants (Actual) | Interventional | 2010-02-28 | Completed |
| Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial [NCT00718796] | Phase 3 | 300 participants (Anticipated) | Interventional | 2008-04-30 | Completed |
| Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke [NCT02549846] | Phase 4 | 270 participants (Actual) | Interventional | 2015-09-30 | Completed |
| A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone in Healthy Male Volunteers [NCT02730689] | Phase 1 | 66 participants (Actual) | Interventional | 2014-12-31 | Completed |
| A 26-Week, Double Blind, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) With Atorvastatin (80 mg) in Subjects With Hypercholesterolaemia and Coronary Heart Disease or CHD Risk Equivale [NCT00653588] | Phase 3 | 0 participants | Interventional | 2003-04-30 | Completed |
| A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES) [NCT00653744] | Phase 3 | 1,700 participants (Anticipated) | Interventional | 2002-03-31 | Completed |
| A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. [NCT00654446] | Phase 3 | 442 participants | Interventional | 2002-09-30 | Completed |
| PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study (POISE-3) [NCT02546648] | Phase 3 | 100 participants (Actual) | Interventional | 2015-02-28 | Completed |
| A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous [NCT00654602] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2002-02-28 | Completed |
| Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma [NCT04491643] | Phase 2 | 48 participants (Anticipated) | Interventional | 2020-09-01 | Recruiting |
| Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS) [NCT00660764] | | 0 participants | Observational | 2003-05-31 | Completed |
| Comparison of the Effect Noted in The Apo/Apo-1 Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome CENTAURUS Study [NCT00665834] | Phase 4 | 18 participants (Actual) | Interventional | 2006-04-30 | Completed |
| Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia [NCT04061824] | Phase 4 | 150 participants (Actual) | Interventional | 2016-05-24 | Completed |
| A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia. [NCT02770261] | Phase 3 | 219 participants (Actual) | Interventional | 2015-12-31 | Completed |
| DP-R208 Pharmacokinetic Study Phase I [NCT02709187] | Phase 1 | 37 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease [NCT00929734] | Phase 2 | 99 participants (Actual) | Interventional | 2010-03-31 | Completed |
| StAtins for Venous Event Reduction in Patients With Venous Thromboembolism: A Pilot Study Assessing Feasibility of an RCT to Evaluate if Generic Rosuvastatin Reduces the Risk of Recurrent VTE in Patients With Symptomatic Major VTE. [NCT02679664] | Phase 2 | 312 participants (Actual) | Interventional | 2016-11-30 | Active, not recruiting |
| Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke [NCT02643784] | Phase 4 | 100 participants (Anticipated) | Interventional | 2015-12-31 | Not yet recruiting |
| A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to [NCT01154036] | Phase 3 | 1,547 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Randomized, Double-Blind, Multicenter, Trial to Assess the Effect of High & Low Doses of ZD4522 on Progression of Carotid Artery Atheroma in Moderately Hypercholesterolemic Subjects With Asymptomatic Carotid Stenosis After 24 Months of Dosing. [NCT00654394] | Phase 3 | 200 participants (Anticipated) | Interventional | 2000-01-31 | Completed |
| Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT) [NCT00815659] | Phase 4 | 97 participants (Actual) | Interventional | 2008-12-31 | Completed |
| A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Vaptor 20mg (Rosuvastatin) Tablet and Crestor 20mg (Rosuvastatin) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects [NCT05637060] | | 36 participants (Actual) | Interventional | 2022-11-24 | Completed |
| A Prospective, Randomized Study to Determine the Effect of Ezetimibe in Addition to Rosuvastatin on Lipids in Participants With the Hypercholesterolemia Associated With HIV Antiretroviral Therapy [NCT00908011] | | 43 participants (Actual) | Interventional | 2009-06-30 | Completed |
| A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolem [NCT04669041] | Phase 3 | 305 participants (Actual) | Interventional | 2020-12-08 | Completed |
| A Randomized, Double-blind, Active-controlled, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2071 and AD-2073 in Patients With Primary Hypercholesterolemia and Essential Hypertension [NCT04158076] | Phase 3 | 131 participants (Actual) | Interventional | 2020-01-23 | Completed |
| Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial [NCT02859480] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting |
| Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis [NCT00679510] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2004-02-29 | Completed |
| A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia [NCT02827903] | Phase 3 | 237 participants (Actual) | Interventional | 2016-01-15 | Completed |
| A Phase 1, Open-label Study to Evaluate the Influence of Fedratinib on the Pharmacokinetics of Transporter Probe Substrates (Digoxin, Rosuvastatin, and Metformin) in Healthy Adult Subjects [NCT04231435] | Phase 1 | 24 participants (Actual) | Interventional | 2019-12-18 | Completed |
| [NCT01598363] | Phase 1 | 32 participants (Actual) | Interventional | 2012-06-30 | Completed |
| A 6-Week, Randomised, Open-Label, Parallel Group, Multi-Centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Non-Diabetic Metabolic Syndrome Subjects With Raised LDL-C [NCT00335699] | Phase 4 | 370 participants | Interventional | 2005-08-31 | Completed |
| Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction [NCT04974814] | | 99 participants (Anticipated) | Interventional | 2021-05-26 | Recruiting |
| Exploratory Study of New Imaging Biomarkers for Measurement of Carotid Plaque Inflammation [NCT00689416] | Early Phase 1 | 74 participants (Anticipated) | Interventional | 2007-12-31 | Completed |
| A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia [NCT04659070] | Phase 3 | 156 participants (Anticipated) | Interventional | 2020-07-15 | Recruiting |
| A Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Effect of Food on Multiple Rising Oral Doses of BI 1839100 (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and the Effect of Multiple Doses of BI 1839100 on the Sin [NCT05738291] | Phase 1 | 58 participants (Anticipated) | Interventional | 2023-04-26 | Recruiting |
| A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers [NCT02951962] | Phase 1 | 60 participants (Anticipated) | Interventional | 2016-08-31 | Completed |
| Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis [NCT05731596] | Phase 3 | 46 participants (Anticipated) | Interventional | 2023-06-30 | Not yet recruiting |
| A Phase 1, Open-Label, Two-Part, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Voxelotor on the Pharmacokinetics of Selected CYP and Transporter Probe Substrates in Healthy Participants [NCT05981365] | Phase 1 | 18 participants (Actual) | Interventional | 2023-04-17 | Completed |
| Effect of Crestor on the Kinetics of Plasma Apolipoproteins: Dose-Response Study [NCT00214617] | Phase 4 | 8 participants | Interventional | 2005-01-31 | Completed |
| A Phase 2 Multiple-Dose Study to Characterize the Pharmacokinetics of RVX000222 Capsule Formulation in Combination With Either Atorvastatin or Rosuvastatin in Patients With Dyslipidemia [NCT01863225] | Phase 2 | 13 participants (Actual) | Interventional | 2013-05-31 | Terminated |
| Effect of Rosuvastatin in the Mobilization of Endothelial Progenitor Cells and Graft Vascular Function Following Creation of Arteriovenous Fistula in Diabetic Patients With Chronic Renal Failure [NCT01863914] | Phase 2 | 60 participants (Actual) | Interventional | 2012-11-30 | Completed |
| [NCT01872845] | | 671 participants (Actual) | Interventional | 2013-06-12 | Completed |
| Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants [NCT05906836] | Phase 1 | 28 participants (Anticipated) | Interventional | 2023-07-27 | Recruiting |
| Effects of Tight-control Strategy With and Without Rosuvastatin on Progression of Subclinical Carotid and Coronary Atherosclerosis in Psoriatic Arthritis- a Randomized Controlled Study [NCT04176978] | | 0 participants (Actual) | Interventional | 2021-04-01 | Withdrawn(stopped due to Lack of funding) |
| Transporter Profiling Study for P-glycoprotein 1 (P-gp), Organic Anion Transporter 1 (OAT1), Organic Anion Transporter 3 (OAT3), Organic Cation Transporter 2 (OCT2), Multidrug and Toxin Extrusion Protein 1 (MATE1), Multidrug and Toxin Extrusion Protein 2- [NCT05741372] | | 30 participants (Anticipated) | Interventional | 2023-04-25 | Recruiting |
| A Single Centre, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects [NCT01489943] | Phase 1 | 24 participants (Actual) | Interventional | 2011-09-19 | Completed |
| Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients [NCT01490398] | Phase 4 | 56 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetimiBe/Rosuvastatin Diabetic Dislipidemia With Hypertriglyceridaemia [NCT04700436] | Phase 4 | 240 participants (Anticipated) | Interventional | 2020-01-03 | Recruiting |
| Heart Outcomes Prevention Evaluation-3 [NCT00468923] | Phase 4 | 12,705 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation [NCT01245894] | Phase 4 | 87 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin [NCT00487136] | Phase 1 | 45 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia [NCT00506961] | Phase 4 | 90 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome [NCT01245803] | Phase 4 | 400 participants (Anticipated) | Interventional | 2010-04-30 | Recruiting |
| A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure [NCT00505154] | Phase 3 | 75 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Impact of Three Months of Rosuvastatin Treatment on Peripheral Endothelial Function, Inflammatory Markers in the Blood and the Skeletal Muscle and on Postnatal Vasculogenesis in Patients With Severe Chronic Heart Failure [NCT00176332] | Phase 2 | 40 participants | Interventional | 2004-03-31 | Completed |
| A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers [NCT02982798] | Phase 1 | 40 participants (Actual) | Interventional | 2017-07-06 | Completed |
| Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease [NCT04824911] | Phase 2 | 424 participants (Anticipated) | Interventional | 2021-03-23 | Recruiting |
| The Effect of BI 730357 on the Pharmacokinetics of Rosuvastatin, Digoxin, Metformin and Furosemide Given as a Cocktail - an Open-label, Non-randomised, 2-period Fixed-sequence Trial in Healthy Subjects [NCT04590937] | Phase 1 | 15 participants (Actual) | Interventional | 2020-10-20 | Completed |
| [NCT02933658] | Phase 1 | 71 participants (Actual) | Interventional | 2015-11-30 | Completed |
| Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation. [NCT00554138] | | 24 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome [NCT06053983] | Phase 4 | 126 participants (Actual) | Interventional | 2023-01-01 | Completed |
| Randomized Placebo-controlled Trial of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risk and Inflammation [NCT01218802] | Phase 2 | 147 participants (Actual) | Interventional | 2011-02-28 | Completed |
| [NCT01831479] | Phase 1 | 36 participants (Actual) | Interventional | 2011-08-31 | Completed |
| A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy Subjects [NCT05368805] | Phase 1 | 32 participants (Actual) | Interventional | 2022-03-02 | Completed |
| SCH 058235: Assessment of a Multiple-Dose Drug Interaction Between Ezetimibe and Rosuvastatin in Healthy Hypercholesterolemic Subjects [NCT00651144] | Phase 1 | 40 participants (Actual) | Interventional | 2003-03-31 | Completed |
| The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential [NCT05444556] | Phase 1 | 113 participants (Actual) | Interventional | 2022-07-07 | Completed |
| Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study [NCT00228514] | Phase 3 | 40 participants | Interventional | 2004-02-29 | Completed |
| A Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre, Phase III Study to Assess the Impact of Rosuvastatin Treatment for 26 Weeks (Titrated to a Maximum Dose of 40mg Once Daily) on Left Ventricular Function, Cytokines and Lipid Para [NCT00240292] | Phase 3 | 160 participants | Interventional | 2003-02-28 | Completed |
| A Placebo-Controlled, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in Subjects With Type 2 Diabetes Currently Treated With Lipid-Lowering Therapy [NCT00251680] | Phase 3 | 400 participants (Actual) | Interventional | 2005-10-31 | Completed |
| A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of [NCT00329173] | Phase 3 | 1,000 participants | Interventional | 2003-11-30 | Completed |
| Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury [NCT00329758] | Phase 2 | 20 participants (Actual) | Interventional | 2006-07-31 | Completed |
| Rosuvastatin Affecting Aortic Valve Endothelium - RAAVE [NCT00114491] | | 200 participants | Observational | 2003-09-30 | Completed |
| Rho Kinase in Patients With Atherosclerosis: Effects of Statins - A Double Blind, Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin [NCT00115830] | Phase 3 | 40 participants | Interventional | 2004-12-31 | Completed |
| Rosuvastatin for Primary Prevention in Acute Aortic Syndrome/Aortic Aneurysm Patients With Low to Average Low-density Lipoprotein Cholesterol Level [NCT04699279] | | 300 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
| The Effect of Statins on the Urinary Proteome [NCT00464503] | | 7 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126 [NCT00117494] | Phase 4 | 86 participants | Interventional | 2005-10-31 | Completed |
| An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants [NCT04515628] | Phase 1 | 22 participants (Actual) | Interventional | 2020-08-02 | Completed |
| Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial [NCT01798602] | Phase 2 | 8 participants (Actual) | Interventional | 2009-12-31 | Terminated(stopped due to H1N1 pandemic concluded) |
| A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C [NCT01105975] | Phase 2 | 398 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Clinical Trial to Assess the Pharmacokinetic Characteristics of CJ-30060 in Healthy Male Subjects [NCT03009474] | Phase 1 | 52 participants (Actual) | Interventional | 2015-02-28 | Completed |
| A Randomized Comparison of Low-dose Versus High-dose Rosuvastatin on Optical Coherence Tomography Based Early Vascular Healing for Patients With Acute Coronary Syndrome [NCT03007524] | Phase 4 | 80 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| Influence of Intensive Lipid-lowering With Statin and Ezetimib Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain (The FLOW-PROMOTE Study) [NCT04737408] | Phase 3 | 120 participants (Anticipated) | Interventional | 2020-05-13 | Recruiting |
| Phase 2 Trial of Rosuvastatin (Crestor®) Combined With Standard Chemoradiation Therapy in the Treatment of High-Risk Locally Advanced Rectal Cancer [NCT02569645] | Phase 2 | 45 participants (Actual) | Interventional | 2015-11-30 | Completed |
| Statin Polyp Prevention Trial in Patients With Resected Colon Cancer [NCT01011478] | Phase 3 | 406 participants (Actual) | Interventional | 2010-03-31 | Terminated |
| Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure [NCT00206310] | Phase 3 | 5,013 participants | Interventional | 2003-09-30 | Completed |
| A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angi [NCT00240318] | Phase 3 | 450 participants | Interventional | 2002-11-30 | Completed |
| A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS [NCT04253353] | Phase 1 | 12 participants (Actual) | Interventional | 2020-02-06 | Completed |
| Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C [NCT00446940] | Phase 2 | 16 participants (Anticipated) | Interventional | 2006-12-31 | Completed |
| Pharmacokinetic Evaluation of Single-dose Rosuvastatin 10 mg When Co-administered With Steady-state Tipranavir 500 mg/Ritonavir 200 mg TPV/r) B.I.D. in Healthy Adult Volunteers [NCT00344123] | Phase 1 | 29 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury? [NCT00457652] | Phase 4 | 24 participants (Actual) | Interventional | 2007-06-30 | Completed |
| The RITA-study -- An Open Study to Evaluate the Blood Lipid Lowering Effect of Rosuvastatin Versus Fluvastatin and the Bilateral Interaction Between Everolimus and Rosuvastatin in Renal Transplant Recipients [NCT01524601] | Phase 4 | 20 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer [NCT01524653] | Phase 2 | 38 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment [NCT03540355] | Phase 3 | 312 participants (Anticipated) | Interventional | 2021-01-29 | Recruiting |
| A Randomized, Open Label, Cross-over Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers [NCT01526317] | Phase 1 | 36 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI) [NCT01526460] | Phase 2 | 146 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins [NCT01547377] | | 76 participants (Actual) | Interventional | 2008-01-31 | Completed |
| A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers [NCT01548157] | Phase 1 | 28 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage [NCT00364559] | Phase 2 | 75 participants (Actual) | Interventional | 2006-08-31 | Completed |
| A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) [NCT05076877] | Phase 1 | 20 participants (Actual) | Interventional | 2021-09-17 | Completed |
| ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals [NCT00396240] | Phase 4 | 1,294 participants | Interventional | 2002-02-28 | Withdrawn(stopped due to study cancelled prior to FSI) |
| A 12-week Randomized, Open-label 3-arm, Parallel Group, Multicenter Phase IIIb Study Comparing Efficacy and Safety of Rosuvastatin 20mg and 40mg With That of Atorvastatin 80 mg in Subjects With Acute Coronary Syndromes [NCT00214630] | Phase 3 | 825 participants (Actual) | Interventional | 2003-12-31 | Completed |
| Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies [NCT00079638] | Phase 4 | 300 participants | Interventional | 2004-04-30 | Completed |
| Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA) [NCT00184951] | Phase 2 | 30 participants | Interventional | 2004-04-30 | Completed |
| [NCT02968160] | Phase 4 | 55 participants (Actual) | Interventional | 2016-10-31 | Terminated(stopped due to Due to poor enrollment rate) |
| A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase III Study Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR) [NCT00225589] | Phase 3 | 840 participants | Interventional | 2002-08-31 | Completed |
| Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia [NCT02979704] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasart [NCT03156842] | Phase 3 | 138 participants (Actual) | Interventional | 2017-05-29 | Completed |
| A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo [NCT00240331] | Phase 3 | 2,776 participants (Actual) | Interventional | 2003-01-31 | Completed |
| A Phase 1, Three-Part, Open-label Study in Healthy Adult Volunteers to Assess Vadadustat as a Perpetrator in Drug-Drug Interactions With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin [NCT03801733] | Phase 1 | 134 participants (Actual) | Interventional | 2018-06-17 | Completed |
| Use of Rosuvastatin in Integral Management of Abdominal Sepsis [NCT00357123] | Phase 2 | 60 participants (Anticipated) | Interventional | 2006-08-31 | Recruiting |
| [NCT02704702] | Phase 1 | 36 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Treatment With Rosuvastatin in Patients With Hepatitis C [NCT00371579] | | 0 participants (Actual) | Interventional | 2006-10-31 | Withdrawn(stopped due to no actual patients recruited within year 1 after ethical committee approval) |
| Depression and Cardiovascular Risk Markers: Effects of Rosuvastatin Therapy [NCT00951132] | Phase 2 | 0 participants (Actual) | Interventional | 2009-09-30 | Withdrawn(stopped due to Failure to include patients) |
| A Multicentre Study Comparing the Efficacy of Rosuvastatin With Atorvastatin When Given for a Period of 16 Wks to Subjects With Coronary Heart Disease & a Previously Performed Percutaneous Coronary Intervention [NCT00235950] | Phase 4 | 255 participants | Interventional | 2004-01-31 | Completed |
| An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Rosuvastatin Ca Tab 40 mg [Torrent,India] Versus Crestor 40 mg Tab [ AstraZeneca Pharmaceuticals LP, USA] in Healthy Subjects-Fasted Condition. [NCT02962310] | Phase 1 | 48 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Rosuvastatin Pharmacokinetic (PK) Study in Caucasian and Asian Morbid Obese Patients [NCT02215174] | Phase 1 | 21 participants (Actual) | Interventional | 2015-02-28 | Terminated(stopped due to IRB approval expired) |
| Interventions Study for the Control of Diabetes Mellitus Type 2 in Obese Women [NCT00262548] | Phase 4 | 100 participants (Anticipated) | Interventional | 2005-10-31 | Completed |
| An Open-label, Randomised, Multi-centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb Hypercholesterolaemia [NCT00239330] | Phase 3 | 824 participants | Interventional | 2003-06-30 | Completed |
| A Randomised, Double-blind, Placebo-controlled, Crossover Pilot Study to Define the High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTORâ„¢) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT) [NCT00240266] | Phase 3 | 15 participants | Interventional | 2003-08-31 | Completed |
| A Randomised, Double-Blind, Placebo Controlled, Crossover Dose-Ranging Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome [NCT00240305] | Phase 3 | 15 participants | Interventional | 2004-04-30 | Completed |
| A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat or Placebo When Co-Administered With High Dose Statin Therapy in Subjects With Primary Hypercholesterolemia [NCT00249899] | Phase 3 | 649 participants (Actual) | Interventional | 2005-11-30 | Terminated(stopped due to Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents) |
| Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial [NCT00315510] | Phase 2 | 20 participants | Interventional | 2006-04-30 | Completed |
| Phase 4 Clinical Trial to Examine the Role of Rosuvastatin and Exercise Treatment in Modulating Inflammatory Response in Hypercholesterolemic Subjects [NCT00295373] | Phase 4 | 48 participants | Interventional | 2006-02-28 | Active, not recruiting |
| Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS [NCT00296387] | Phase 3 | 1,160 participants (Anticipated) | Interventional | 2006-01-31 | Completed |
| A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure [NCT00336336] | Phase 3 | 6,975 participants (Actual) | Interventional | 2002-08-31 | Completed |
| Anti-Inflammatory Effect of Statins in the Human Endotoxin Model [NCT00309374] | Phase 1 | 6 participants | Interventional | 2006-03-31 | Completed |
| Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy [NCT01622777] | Phase 2 | 34 participants (Actual) | Interventional | 2010-02-28 | Completed |
| [NCT01623921] | | 100 participants (Anticipated) | Interventional | 2012-08-31 | Not yet recruiting |
| Perioperative Statin for Depression in Patients Undergoing Coronary Artery Bypass Surgery [NCT01624857] | Phase 3 | 400 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
| Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy [NCT01634906] | | 55 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Peking and Rotterdam on Mission to Reduce Coronary Artery Disease [NCT01653119] | | 1,000 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
| [NCT01660919] | Phase 4 | 160 participants (Anticipated) | Interventional | 2011-10-31 | Completed |
| The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial [NCT03889314] | Phase 4 | 25 participants (Actual) | Interventional | 2019-04-26 | Active, not recruiting |
| The Therapeutic Effects of Combination of Statins With Berberine on the Patients With Hyperlipemia:a Single-center, Open Clinical Trial [NCT01697735] | Phase 4 | 24 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to Because of lack of participants and funds) |
| The Endothelium Dysfunction in Patients of Obstructive Sleep Apnea Syndrome [NCT01699126] | Phase 4 | 46 participants (Actual) | Interventional | 2010-05-31 | Completed |
| Study of Bioequivalence Between Two Formulations of 20 mg Rosuvastatin Calcium Tablets, Administered Under Fasting to Healthy Volunteers of Both Genders, Being the Test Formulation Manufactured by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKli [NCT01711749] | Phase 1 | 60 participants (Actual) | Interventional | 2013-02-25 | Completed |
| Pilot Study of Statins in Patients With Clonal Cytopenia of Undetermined Significance (CCUS) and Myelodysplastic Syndromes (MDS) [NCT05483010] | Phase 2 | 16 participants (Anticipated) | Interventional | 2024-01-03 | Not yet recruiting |
| A Two-Part, Open-label, Sequential, Double Cohort, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Rosuvastatin When Co Administered With Darapladib in Healthy Adult Subjects [NCT01751074] | Phase 1 | 18 participants (Actual) | Interventional | 2012-12-17 | Completed |
| Multi-institutional, Randomized, Double-Blind, Placebo-Control, Factorial Design, 4-arms, 8 Week Administration, Phase 3 Clinical Study for Patients With Hypertension Associated With Dyslipidemia [NCT01764295] | Phase 3 | 150 participants (Anticipated) | Interventional | 2012-09-30 | Completed |
| The Prediction of Extent and Risk Profile of Coronary Atherosclerosis (Examined by Intravascular Ultrasound, Virtual Histology and Optical Coherence Tomography) and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques. [NCT01773512] | Phase 4 | 60 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
| Randomized, Open Label, Multiple-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects [NCT01775579] | Phase 1 | 36 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Effects of Pediatric Liver Adiposity on Statin Disposition and Response [NCT04903223] | Phase 1 | 50 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| The Influence of Statins on Glucose Homeostasis and the Biomarkers of Diabetes in Subjects With Impaired Fasting Glucose [NCT01816997] | Phase 4 | 160 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting |
| A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects [NCT01823133] | Phase 1 | 30 participants (Anticipated) | Interventional | 2013-04-30 | Completed |
| Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial [NCT05306990] | | 108 participants (Actual) | Interventional | 2017-04-20 | Completed |
| A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin [NCT01730040] | Phase 3 | 355 participants (Actual) | Interventional | 2012-10-31 | Completed |
| A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients [NCT05747768] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-07-15 | Recruiting |
| Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia [NCT01466608] | Phase 4 | 21 participants (Actual) | Interventional | 2011-11-30 | Completed |
| A Phase I Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SAD and MAD of YN001 in Healthy Subjects and MAD of YN001 in Patients With Coronary Atherosclerosis [NCT06048588] | Phase 1 | 128 participants (Anticipated) | Interventional | 2023-10-08 | Recruiting |
| A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS [NCT05788328] | Phase 1 | 16 participants (Actual) | Interventional | 2023-03-27 | Terminated(stopped due to The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.) |
| Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial [NCT04359095] | Phase 2/Phase 3 | 650 participants (Actual) | Interventional | 2020-08-18 | Completed |
| Multicenter, Parallel-group, Double-blind, Randomized, Active-controlled, Dose-ranging Study to Assess the Safety, Efficacy, and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors, in Subjects With Dyslipidemia [NCT02977065] | Phase 2 | 62 participants (Actual) | Interventional | 2017-03-23 | Completed |
| An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/20 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 20 mg in Healthy Volunteers [NCT01929512] | Phase 1 | 72 participants (Actual) | Interventional | 2013-06-30 | Completed |
| A Randomized, Open-label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Bisoprolol and Rosuvastatin in Healthy Adult Volunteers [NCT01925300] | Phase 1 | 0 participants (Actual) | Interventional | 2013-07-31 | Withdrawn |
| A Phase â… Study to Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin in Healthy Male Volunteers [NCT01921946] | Phase 1 | 50 participants (Actual) | Interventional | 2013-08-31 | Completed |
| Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients [NCT02262143] | Phase 3 | 362 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis [NCT00979121] | Phase 3 | 745 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to stopped for futility) |
| Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications [NCT00970606] | | 7 participants (Actual) | Interventional | 2009-10-31 | Terminated(stopped due to Inability to recruit participants since H1N1 epidemic resolved.) |
| Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment [NCT03527069] | Phase 3 | 298 participants (Anticipated) | Interventional | 2021-01-29 | Recruiting |
| Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Subjects With Type IIa and IIb Hypercholesterolaemia [NCT00631189] | Phase 4 | 668 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Early Intensive Treatment With Statins Improves Left Ventricular Function in Patients With Acute Myocardial Infarction. [NCT01923077] | Phase 2 | 140 participants (Actual) | Interventional | 2010-04-30 | Active, not recruiting |
| AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY TO EVALUATE THE EFFECT OF A SINGLE ORAL DOSE OF ARV-471 (PF-07850327) ON THE PHARMACOKINETICS OF ROSUVASTATIN IN HEALTHY PARTICIPANTS [NCT05652660] | Phase 1 | 12 participants (Actual) | Interventional | 2022-12-09 | Completed |
| A Single Center, Open-label, Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin in Healthy Subjects [NCT02542969] | Phase 1 | 25 participants (Actual) | Interventional | 2015-09-30 | Completed |
| Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients [NCT05338723] | Phase 3 | 50 participants (Anticipated) | Interventional | 2020-09-15 | Recruiting |
| An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants [NCT04124003] | Phase 1 | 28 participants (Actual) | Interventional | 2019-10-08 | Completed |
| The Prognosis of Lipid Reprogramming With the HMG-CoA Reductase Inhibitor, Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients [NCT04776889] | Phase 4 | 70 participants (Actual) | Interventional | 2019-01-15 | Completed |
| Evaluation of the Effect of Rosuvastatin on Cisplatin-induced Nephrotoxicity and Ototoxicity [NCT04817904] | Phase 2 | 65 participants (Anticipated) | Interventional | 2020-11-17 | Recruiting |
| A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ) [NCT01660191] | Phase 4 | 134 participants (Actual) | Interventional | 2011-12-31 | Completed |
| A Multicenter, Randomized, Double-Blind, Titration Study to Evaluate the Efficacy and Safety of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia at Risk for Coronary Heart Disease [NCT00783263] | Phase 3 | 440 participants (Actual) | Interventional | 2008-11-30 | Completed |
| A Phase III Multi-Center, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Clinical Trial in High-Risk Type 2 Diabetes Mellitus (T2DM) Subjects With Coronary Artery Disease (CAD) to Determine Whether Bromodomain Extraterminal Domain (BET) Inhi [NCT02586155] | Phase 3 | 2,425 participants (Actual) | Interventional | 2015-11-30 | Completed |
| Genome-wide Analysis of Lipid-lowering Efficacy and Drug Level of the Two Commonly Used Statins, Simvastatin and Rosuvastatin. [NCT04921657] | | 362 participants (Actual) | Observational | 2014-11-30 | Completed |
| Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed [NCT04895059] | Phase 1 | 36 participants (Actual) | Interventional | 2017-04-30 | Completed |
| RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial) [NCT03044665] | | 3,780 participants (Anticipated) | Interventional | 2017-03-15 | Recruiting |
| A Randomized, Double-blind, Placebo-controlled, Multicenter Parallel Group Phase 3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects [NCT02546323] | Phase 3 | 543 participants (Actual) | Interventional | 2015-09-17 | Completed |
| A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia [NCT03217409] | Phase 4 | 85 participants (Actual) | Interventional | 2017-08-10 | Completed |
| Statin Therapy In Cardiac Surgery [NCT01573143] | Phase 4 | 1,922 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis [NCT01613794] | | 255 participants (Actual) | Interventional | 2012-12-31 | Completed |
| An Open-label, Randomized, Multi-centre, Phase IVb, Parallel Study Group to Compare the Efficacy and Safety of 5 mg and 10 mg Rosuvastatin [NCT01613729] | Phase 4 | 2,000 participants (Anticipated) | Interventional | 2012-07-31 | Enrolling by invitation |
| A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension [NCT03088254] | Phase 3 | 126 participants (Actual) | Interventional | 2016-09-20 | Completed |
| HDL Increased Plaque Stabilization in the Elderly [NCT00127218] | Phase 3 | 145 participants (Actual) | Interventional | 2003-09-30 | Completed |
| Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study [NCT03418974] | Phase 4 | 10,000 participants (Actual) | Interventional | 2017-11-01 | Active, not recruiting |
| YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering [NCT01837823] | Phase 2 | 91 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treat [NCT00379249] | Phase 3 | 8,000 participants | Interventional | 2002-02-28 | Completed |
| Influence of Autoinhibition/Autoinduction and CYP2B6 Genetic Variations on CYP2B6 Activity and Drug Interactions in Healthy Volunteers [NCT02401256] | Phase 4 | 70 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Pilot Study of the Effect of Low-Dose Rosuvastatin on Endothelial Function, Oxidative Stress and Inflammatory Parameters in HIV-Infected Individuals With Low HDL Cholesterol Levels and Low to Normal LDL Cholesterol Levels [NCT00986999] | Phase 2/Phase 3 | 7 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to poor enrollment) |
| Randomized, Placebo Controlled, Pilot Trial of Statin Use in Burn Patients [NCT00978419] | Phase 2 | 40 participants (Actual) | Interventional | 2010-03-31 | Completed |
| National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia. [NCT04602754] | Phase 3 | 228 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
| A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI [NCT02317016] | Phase 1 | 44 participants (Actual) | Interventional | 2015-03-10 | Completed |
| Clinical Trial to Evaluate the Efficacy and Safety of Suvaro®OD Tablet in Patients With Dyslipidemia [NCT06153433] | Phase 4 | 112 participants (Anticipated) | Interventional | 2023-11-06 | Recruiting |
| A PHASE 1, OPEN -LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ROSUVASTATIN AND MIDAZOLAM IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OBESITY [NCT04621227] | Phase 1 | 16 participants (Actual) | Interventional | 2020-12-15 | Completed |
| CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction [NCT02740699] | Phase 4 | 108 participants (Actual) | Interventional | 2016-04-11 | Terminated(stopped due to Principal Investigator resigned and closed program) |
| Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions [NCT04744571] | | 200 participants (Anticipated) | Interventional | 2021-02-28 | Enrolling by invitation |
| Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial [NCT00371501] | Phase 4 | 72 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (EVALUATE-STEMI Trial): a Prospective, Mu [NCT05613426] | Phase 4 | 330 participants (Anticipated) | Interventional | 2023-04-03 | Recruiting |
| A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia [NCT00300430] | Phase 3 | 1,911 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH) [NCT02226198] | Phase 3 | 20 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Dapagliflozin on Cholesterol Metabolism in DM2: Dissecting Its Effect on Dyslipidemia by Using Stable Isotope Based Cholesterol and Glucose Fluxes [NCT03074630] | Phase 4 | 12 participants (Actual) | Interventional | 2016-05-31 | Completed |
| Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus [NCT01544309] | | 1,049 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Adjunctive Rosuvastatin Treatment for prEventing coMplIcationS In Renal Ablation [NCT01899027] | Phase 4 | 112 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
| Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial [NCT05661552] | Phase 4 | 102 participants (Anticipated) | Interventional | 2022-12-01 | Recruiting |
| A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled [NCT03026933] | Phase 3 | 215 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Rosuvastatin 1.2mg in Situ Gel Combined With 1:1 Mixture of Autologous Platelet-rich Fibrin and Porus- Hydroxyappatite Bone Graft in Surgical Treatment of Mandibular Degree II Furcation Defects: A Randomized Clinical Control Trial [NCT02369250] | Phase 4 | 110 participants (Actual) | Interventional | 2013-11-30 | Completed |
| Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients: Clinical Impact of Genetic Variation in Statin Disposition [NCT02364258] | Phase 1 | 28 participants (Actual) | Interventional | 2014-07-31 | Completed |
| Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography [NCT02341794] | | 60 participants (Anticipated) | Interventional | 2015-01-31 | Recruiting |
| Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia [NCT06102863] | Phase 2 | 38 participants (Anticipated) | Interventional | 2023-04-01 | Recruiting |
| Non-interventional, Multicenter Clinical Trial to Investigate the Efficacy of Rosuvastatin in Patients With Hyperlipidemia and Other Cardiovascular Risk Factors. [NCT03329729] | | 4,700 participants (Actual) | Observational | 2018-02-01 | Completed |
| A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects [NCT05154123] | Phase 1 | 29 participants (Actual) | Interventional | 2021-11-16 | Completed |
| An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects [NCT03175835] | Phase 1 | 30 participants (Actual) | Interventional | 2017-05-08 | Completed |
| [NCT02411903] | Phase 4 | 160 participants (Anticipated) | Interventional | 2015-03-31 | Enrolling by invitation |
| A 4-Part Phase 1 Study to Evaluate the Effect of GDC-0853 on the Pharmacokinetics of Midazolam, Rosuvastatin, and Simvastatin and the Effect of Itraconazole on the Pharmacokinetics of GDC-0853 [NCT03174041] | Phase 1 | 63 participants (Actual) | Interventional | 2017-04-18 | Completed |
| Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) [NCT04481789] | Phase 1 | 84 participants (Actual) | Interventional | 2018-10-17 | Completed |
| [NCT02390375] | Phase 3 | 348 participants (Actual) | Interventional | 2014-11-30 | Completed |
| SystemIc iNflammation and Microvascular diSease PreventIon in psoRiatic diseasE [NCT04417114] | Phase 4 | 0 participants (Actual) | Interventional | 2021-04-01 | Withdrawn(stopped due to The study was not funded.) |
| Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients [NCT02420899] | | 100 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT [NCT03233243] | Phase 4 | 40 participants (Actual) | Interventional | 2020-07-27 | Completed |
| A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of JLP-1310 in Healthy Male Volunteers [NCT02449187] | Phase 1 | 16 participants (Actual) | Interventional | 2017-08-02 | Completed |
| Interactions of Herbs With Statin Drugs and Potential Mediation by Drug Transporters [NCT05072405] | Phase 4 | 38 participants (Actual) | Interventional | 2013-01-11 | Completed |
| An Open Label, Randomized, Two Part Study to Evaluate the CYP2C8- and OATP1B1-Mediated Drug-Drug Interaction Potential of GSK1278863 With Pioglitazone and Rosuvastatin as Victims and Trimethoprim as Perpetrator in Healthy Adult Volunteers [NCT02371603] | Phase 1 | 70 participants (Actual) | Interventional | 2015-02-11 | Completed |
| The Study of Berberine Affecting Metabolism, Inflammation Status, Endothelial Function and Thrombotic Events in Patients With Coronary Artery Disease by Remodeling Gut Microbiota [NCT04434365] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2019-06-21 | Active, not recruiting |
| A Phase I, Open-label, Fixed Sequence Crossover Study to Investigate the Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin, a Breast Cancer Resistance Protein Substrate, in Healthy Subjects [NCT05045638] | Phase 1 | 13 participants (Actual) | Interventional | 2021-08-20 | Completed |
| The Effect of Statin Therapy on Bile Acid Physiology and the Microbiome in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study [NCT05912387] | Early Phase 1 | 15 participants (Anticipated) | Interventional | 2023-05-31 | Recruiting |
| Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction [NCT05895123] | Phase 2 | 80 participants (Actual) | Interventional | 2022-10-01 | Completed |
| A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects [NCT04498741] | Phase 1 | 89 participants (Actual) | Interventional | 2020-07-08 | Completed |
| A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Chinese Adult Subjects. [NCT05088343] | Phase 1 | 14 participants (Actual) | Interventional | 2020-09-07 | Completed |
| A Phase 1 Study to Evaluate the Effect of BCX7353 on the Single Dose Pharmacokinetics of the P-gp Substrate Digoxin and the BCRP Substrate Rosuvastatin and the Effect of the P-gp Inhibitor Cyclosporine on the Single Dose Pharmacokinetics of BCX7353 [NCT03136237] | Phase 1 | 54 participants (Actual) | Interventional | 2017-02-17 | Completed |
| Phase III, Multicenter, Randomized, Open-label, Comparative Study to Evaluate Efficacy and Safety of Rosuvastatin + Ezetimibe Versus Simvastatin + Ezetimibe in High Risk Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia [NCT01420549] | Phase 3 | 129 participants (Actual) | Interventional | 2013-03-31 | Completed |
| The Efficacy and Safety of Rosuvastatin for Modifying Bone Mass and Cardiometabolic Disease Outcomes [NCT03113994] | Phase 2 | 8 participants (Actual) | Interventional | 2018-02-26 | Active, not recruiting |
| A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia [NCT00300482] | Phase 3 | 1,445 participants (Actual) | Interventional | 2006-03-31 | Completed |
| A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects. [NCT03010475] | Phase 1 | 41 participants (Actual) | Interventional | 2017-01-05 | Completed |
| An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily [NCT01725230] | Phase 1 | 42 participants (Actual) | Interventional | 2012-11-30 | Completed |
| An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH) [NCT02434497] | Phase 3 | 9 participants (Actual) | Interventional | 2015-06-06 | Completed |
| National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia. [NCT04603508] | Phase 3 | 240 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
| A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis [NCT04847752] | | 1,000 participants (Anticipated) | Observational | 2021-03-01 | Recruiting |
| A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers [NCT01929070] | Phase 1 | 12 participants (Actual) | Interventional | 2013-02-28 | Completed |
| A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinet [NCT05389722] | Phase 1 | 24 participants (Actual) | Interventional | 2022-06-09 | Completed |
| A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia [NCT01890967] | Phase 2 | 527 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial [NCT01813357] | Phase 4 | 84 participants (Actual) | Interventional | 2013-07-02 | Completed |
| An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasar [NCT02995720] | Phase 1 | 60 participants (Actual) | Interventional | 2016-08-26 | Completed |
| 1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial [NCT02985099] | Phase 2/Phase 3 | 80 participants (Actual) | Interventional | 2015-11-30 | Completed |
| A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin [NCT01730053] | Phase 3 | 305 participants (Actual) | Interventional | 2012-11-30 | Completed |
| Evaluation of Ubiquinol on the Association of Statins and Mitochondrial Oxidative Capacity Using 31P Magnetic Resonance Imaging [NCT01702987] | | 22 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Drug Interaction Study of Safinamide and a BCRP Substrate, Rosuvastatin, Concomitantly Administered to Healthy Volunteers [NCT03216304] | Phase 1 | 24 participants (Actual) | Interventional | 2017-05-22 | Completed |
| [NCT03210532] | Phase 3 | 129 participants (Actual) | Interventional | 2016-10-07 | Completed |
| Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy. (YELLOW Trial) [NCT01567826] | Phase 4 | 87 participants (Actual) | Interventional | 2010-05-31 | Completed |
| Polipill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care [NCT05155137] | Phase 3 | 12,268 participants (Anticipated) | Interventional | 2021-12-20 | Recruiting |
| A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia [NCT04398771] | | 1,000 participants (Anticipated) | Observational | 2020-09-01 | Not yet recruiting |
| Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Subjects With Castration-Resistant Prostate Cancer [NCT02592317] | Phase 1 | 23 participants (Actual) | Interventional | 2016-02-12 | Completed |
| Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin [NCT03044873] | Phase 1 | 20 participants (Actual) | Interventional | 2017-02-02 | Completed |
| A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects [NCT06162169] | Phase 1 | 66 participants (Anticipated) | Interventional | 2023-11-25 | Recruiting |
| A Randomized, Single-center, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Korean Patients With Left Ventricular Diastolic Dysfunction and Hyperlipidemia [NCT04433533] | Phase 4 | 200 participants (Anticipated) | Interventional | 2021-01-06 | Recruiting |
| A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors [NCT03954366] | Phase 1 | 36 participants (Actual) | Interventional | 2019-04-25 | Completed |
| An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors [NCT03864042] | Phase 1 | 56 participants (Actual) | Interventional | 2018-01-02 | Active, not recruiting |
| A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase â…¢ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hyper [NCT01918332] | Phase 3 | 168 participants (Actual) | Interventional | 2012-04-30 | Completed |
| An Open-Label, 2-Part Study to Investigate the Effect of Lasmiditan on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Volunteers [NCT04749914] | Phase 1 | 96 participants (Actual) | Interventional | 2021-02-15 | Completed |
| A Phase I, Open-label, Fixed-sequence, Two-period, Crossover, Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of Ganaplacide and Lumefantrine Combination on the Pharmacokinetics of Midazolam, Repaglinide, Dextromethorphan, Metformin, [NCT05236530] | Phase 1 | 48 participants (Actual) | Interventional | 2022-03-09 | Completed |
| Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions [NCT01241903] | Phase 1 | 54 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Dapagliflozin Effect in Cognitive Impairment in Stroke Trial [NCT05565976] | Phase 2/Phase 3 | 270 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial [NCT02516826] | Phase 2 | 504 participants (Anticipated) | Interventional | 2015-08-31 | Not yet recruiting |
| Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin in Healthy Male and Female Subjects (Open-label, Fixed-sequence) [NCT01795937] | Phase 1 | 51 participants (Actual) | Interventional | 2013-02-28 | Completed |
| EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) [NCT05742841] | Phase 4 | 22 participants (Actual) | Interventional | 2023-03-08 | Completed |
| A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin [NCT02477514] | Phase 1 | 18 participants (Actual) | Interventional | 2015-06-30 | Completed |
| A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Ther [NCT02715726] | Phase 3 | 615 participants (Actual) | Interventional | 2016-07-27 | Completed |
| A PHASE 1 STUDY TO EVALUATE THE EFFECTS OF MULTIPLE DOSES OF LY3537982 ON THE SINGLE-DOSE PHARMACOKINETICS OF MIDAZOLAM, DIGOXIN, AND ROSUVASTATIN IN HEALTHY ADULT SUBJECTS [NCT06111521] | Phase 1 | 56 participants (Anticipated) | Interventional | 2023-10-27 | Not yet recruiting |
| Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon [NCT03516955] | | 317 participants (Actual) | Observational | 2014-11-30 | Completed |
| Open-label, One-sequence Crossover Study to Determine the Effects of Multiple Doses of Elinzanetant on the Pharmacokinetics of Rosuvastatin in Healthy Participants [NCT04889287] | Phase 1 | 16 participants (Actual) | Interventional | 2021-05-26 | Completed |
| Efficacy of Locally Delivered 1.2% Rosuvastatin Gel in Non Surgical Treatment of Chronic Periodontitis Patients: A Randomised Clinical Control Trial. [NCT02283515] | Phase 2/Phase 3 | 65 participants (Actual) | Interventional | 2014-01-31 | Completed |
| A Phase I, Fixed-sequence, Open-label Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Substrates of Human Transporters Digoxin (P-gp), Rosuvastatin (OATP1B1/3), Metformin (OCT2, MATE1/2K), and Furosemide (OAT1/3) in Healthy Male Subj [NCT05768360] | Phase 1 | 6 participants (Actual) | Interventional | 2023-04-25 | Completed |
| A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants [NCT05708573] | Phase 1 | 20 participants (Actual) | Interventional | 2023-02-01 | Completed |
| Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound [NCT03529253] | Phase 4 | 30 participants (Anticipated) | Interventional | 2018-04-01 | Recruiting |
| A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary [NCT03526367] | Phase 4 | 0 participants (Actual) | Interventional | 2019-02-20 | Withdrawn(stopped due to Study withdrawn for no sufficient fund support.) |
| A Phase 1, Single-center, Open-label, 2-period, Single-sequence, Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose LX4211 on the Pharmacokinetics of Single-dose Rosuvastatin (Crestor®), a Sensitive Breast Cancer Resistance Protein (BCRP [NCT02300363] | Phase 1 | 24 participants (Actual) | Interventional | 2014-10-31 | Completed |
| Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia [NCT02305355] | Phase 4 | 68 participants (Actual) | Interventional | 2009-02-28 | Completed |
| INvestigating the Lowest Threshold of Vascular bENefits From LDL Cholesterol Lowering With a PCSK9 mAb InhibiTor (Alirocumab) in Patients With Stable Cardiovascular Disease (INTENSITY-HIGH) [NCT03355027] | | 60 participants (Actual) | Interventional | 2017-11-30 | Active, not recruiting |
| A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention [NCT04499859] | Phase 4 | 3,548 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
| A Phase 1, Single-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of DC-806 on the Single Dose Pharmacokinetics of CYP450 Enzyme and Transporter Substrates in Healthy Participants [NCT06092931] | Phase 1 | 28 participants (Anticipated) | Interventional | 2023-10-16 | Active, not recruiting |
| The Effect of Potent Inhibitors of Drug Transporters (Verapamil, Rifampin, Cimetidine, Probenecid) on Pharmacokinetics of a Transporter Probe Drug Cocktail Consisting of Digoxin, Furosemide, Metformin and Rosuvastatin (an Open-label, Randomised, Crossover [NCT03307252] | Phase 1 | 45 participants (Actual) | Interventional | 2017-10-25 | Completed |
| Investigation of Mutual Pharmacokinetic Interactions of Digoxin, Furosemide, Metformin, and Rosuvastatin Given All Together as a Probe Cocktail for Key Drug Transporters (an Open-label, Randomised, Single-dose, Five-way Crossover Study) [NCT02854527] | Phase 1 | 30 participants (Actual) | Interventional | 2016-08-22 | Completed |
| The Effect of Different Doses of Metformin or Furosemide on Rosuvastatin Pharmacokinetics Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-way Crossover Study) [NCT02574845] | Phase 1 | 18 participants (Actual) | Interventional | 2015-10-12 | Completed |
| A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk [NCT02482207] | Phase 4 | 96 participants (Actual) | Interventional | 2015-11-30 | Completed |
| The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study [NCT03372785] | | 240 participants (Anticipated) | Observational [Patient Registry] | 2018-04-10 | Enrolling by invitation |
| A Phase 1, Four-part, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects [NCT03363815] | Phase 1 | 56 participants (Actual) | Interventional | 2017-12-04 | Completed |
| A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects. [NCT03359291] | Phase 1 | 20 participants (Actual) | Interventional | 2017-11-03 | Completed |
| Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination [NCT03907423] | | 70 participants (Actual) | Interventional | 2019-04-01 | Completed |
| An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers [NCT03247140] | Phase 1 | 40 participants (Actual) | Interventional | 2017-06-10 | Completed |
| Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction) [NCT02428374] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
| Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD [NCT03417388] | Phase 4 | 4,422 participants (Anticipated) | Interventional | 2018-02-09 | Recruiting |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy [NCT01709500] | Phase 3 | 249 participants (Actual) | Interventional | 2012-12-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00127218 (2) [back to overview] | Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization) |
| NCT00127218 (2) [back to overview] | Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries |
| NCT00239681 (6) [back to overview] | Time to Bone Fracture |
| NCT00239681 (6) [back to overview] | Time to Death Due to Any Cause |
| NCT00239681 (6) [back to overview] | Time to Development of Diabetes Mellitus |
| NCT00239681 (6) [back to overview] | Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) |
| NCT00239681 (6) [back to overview] | Time to Non-cardiovascular Death |
| NCT00239681 (6) [back to overview] | Time to Venous Thromboembolic Event |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants That Died From Cardiovascular Cause |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants That Died From Any Cause. |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations). |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis. |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause |
| NCT00240331 (7) [back to overview] | Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death) |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1 |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC |
| NCT00296374 (72) [back to overview] | Urinary Albumin/Creatinine Ratio at Week 26 |
| NCT00296374 (72) [back to overview] | Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] |
| NCT00296374 (72) [back to overview] | Urinary Protein/Creatinine Ratio at Week 26. |
| NCT00296374 (72) [back to overview] | Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TG |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TG |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TC |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and TC |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes |
| NCT00296374 (72) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 |
| NCT00296374 (72) [back to overview] | Change From Baseline in eGFR at Week 52 [LOCF] |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C |
| NCT00296374 (72) [back to overview] | Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26. |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52. |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C |
| NCT00296400 (72) [back to overview] | Urinary Albumin/Creatinine Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] |
| NCT00296400 (72) [back to overview] | Urinary Protein/Creatinine Ratio at Week 26. |
| NCT00296400 (72) [back to overview] | Urinary Protein/Creatinine Ratio at Week 52 [LOCF] |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26 |
| NCT00296400 (72) [back to overview] | Change From Baseline in eGFR at Week 52 [LOCF] |
| NCT00296400 (72) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26 |
| NCT00296400 (72) [back to overview] | Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52 |
| NCT00300430 (9) [back to overview] | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study |
| NCT00300430 (9) [back to overview] | Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study |
| NCT00300430 (9) [back to overview] | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Triglycerides From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Total Cholesterol From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit |
| NCT00300482 (8) [back to overview] | Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit |
| NCT00329160 (4) [back to overview] | Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points |
| NCT00329160 (4) [back to overview] | Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) |
| NCT00329160 (4) [back to overview] | Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） |
| NCT00329160 (4) [back to overview] | Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion |
| NCT00355615 (13) [back to overview] | Percent Change in Apolipoprotein B (ApoB) |
| NCT00355615 (13) [back to overview] | Percent Change in LDL-C/HDL-C |
| NCT00355615 (13) [back to overview] | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase |
| NCT00355615 (13) [back to overview] | Percent Change in Non-HDL-C at 12 Weeks |
| NCT00355615 (13) [back to overview] | Percent Change in Non-HDL-C/HDL-C |
| NCT00355615 (13) [back to overview] | Percent Change in TC/HDL-C |
| NCT00355615 (13) [back to overview] | Percent Change in Total Cholesterol (TC) |
| NCT00355615 (13) [back to overview] | Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment |
| NCT00355615 (13) [back to overview] | Percent Change in Triglycerides (TG) |
| NCT00355615 (13) [back to overview] | Percent Change in ApoB/ApoA-1 |
| NCT00355615 (13) [back to overview] | Percent Change in Apolipoprotein A-1 (ApoA-1) |
| NCT00355615 (13) [back to overview] | Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12) |
| NCT00355615 (13) [back to overview] | Percent Change in HDL-C |
| NCT00395486 (12) [back to overview] | Percentage Change of Total Cholesterol (TC) |
| NCT00395486 (12) [back to overview] | Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6 |
| NCT00395486 (12) [back to overview] | Percentage Change of Apolipoprotein A1 (ApoA1) |
| NCT00395486 (12) [back to overview] | Percentage Change of Apolipoprotein B (ApoB) |
| NCT00395486 (12) [back to overview] | Percentage Change of Glucose Level |
| NCT00395486 (12) [back to overview] | Percentage Change of High-Density Lipoprotein-C (HDL-C) |
| NCT00395486 (12) [back to overview] | Percentage Change of Insulin Resistance Using HOMA-R |
| NCT00395486 (12) [back to overview] | Percentage of Subjects Reaching Their LDL-C Target Goal |
| NCT00395486 (12) [back to overview] | Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal |
| NCT00395486 (12) [back to overview] | Percentage Change of Triglycerides (TG) |
| NCT00395486 (12) [back to overview] | Percentage Change of Insulin Resistance Using QUICKI |
| NCT00395486 (12) [back to overview] | Percentage Reduction of Low-Density Lipoprotein-C (LDL-C) |
| NCT00427960 (15) [back to overview] | The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category. |
| NCT00427960 (15) [back to overview] | The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category. |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline(week6) in TC |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6)in Non-HDL-C |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB) |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C) |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1) |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio |
| NCT00427960 (15) [back to overview] | Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C) |
| NCT00427960 (15) [back to overview] | The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio |
| NCT00427960 (15) [back to overview] | The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L |
| NCT00427960 (15) [back to overview] | The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L |
| NCT00427960 (15) [back to overview] | The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L |
| NCT00462748 (1) [back to overview] | Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) |
| NCT00463606 (9) [back to overview] | Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) |
| NCT00473655 (9) [back to overview] | Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) |
| NCT00473655 (9) [back to overview] | HDL-C Increase |
| NCT00473655 (9) [back to overview] | ApoA1 Levels |
| NCT00473655 (9) [back to overview] | hsCRP Reduction |
| NCT00473655 (9) [back to overview] | LDL-C Reduction |
| NCT00473655 (9) [back to overview] | Non-HDL-C Reduction |
| NCT00473655 (9) [back to overview] | Total Cholesterol Reduction |
| NCT00473655 (9) [back to overview] | Adverse Events Reported |
| NCT00473655 (9) [back to overview] | ApoB Levels |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Triglycerides. |
| NCT00479713 (10) [back to overview] | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment |
| NCT00479713 (10) [back to overview] | The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Apolipoprotein B |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Total Cholesterol |
| NCT00479713 (10) [back to overview] | Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio |
| NCT00491530 (7) [back to overview] | Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study |
| NCT00491530 (7) [back to overview] | Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study |
| NCT00525824 (13) [back to overview] | Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in LDL-C After 6 Weeks Monotherapy |
| NCT00525824 (13) [back to overview] | Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in TC/HDL-C After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment |
| NCT00525824 (13) [back to overview] | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment |
| NCT00620542 (16) [back to overview] | Non-HDL-C/HDL-C Blood Level |
| NCT00620542 (16) [back to overview] | Numbers of Patients Showing Regression in PAV |
| NCT00620542 (16) [back to overview] | Numbers of Patients Showing Regression in TAV |
| NCT00620542 (16) [back to overview] | Total Cholesterol Blood Level |
| NCT00620542 (16) [back to overview] | Total Cholesterol/HDL-C Blood Level |
| NCT00620542 (16) [back to overview] | Triglycerides Blood Level |
| NCT00620542 (16) [back to overview] | VLDL-C During the 104 Week Treatment Period |
| NCT00620542 (16) [back to overview] | LDL-C/HDL-C Blood Level |
| NCT00620542 (16) [back to overview] | LDL-C Blood Level |
| NCT00620542 (16) [back to overview] | HDL-C Blood Level |
| NCT00620542 (16) [back to overview] | Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) |
| NCT00620542 (16) [back to overview] | Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) |
| NCT00620542 (16) [back to overview] | Non-HDL-C Blood Level |
| NCT00620542 (16) [back to overview] | Apolipoprotein B Blood Level |
| NCT00620542 (16) [back to overview] | Apolipoprotein A-1 Blood Level |
| NCT00620542 (16) [back to overview] | Apoliprotein B/Apolipoprotein A-1 Blood Level |
| NCT00631189 (9) [back to overview] | Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients |
| NCT00631189 (9) [back to overview] | Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment |
| NCT00631189 (9) [back to overview] | Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment |
| NCT00631189 (9) [back to overview] | Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment |
| NCT00631189 (9) [back to overview] | Compare the Percentage of Variation of C-reactive Protein (CRP) |
| NCT00631189 (9) [back to overview] | Compare the Percentage of Variation of Phospholipase A2 (PLA2) |
| NCT00631189 (9) [back to overview] | Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks |
| NCT00631189 (9) [back to overview] | To Evaluate Clinical and Laboratory Safety |
| NCT00631189 (9) [back to overview] | Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks |
| NCT00680017 (2) [back to overview] | Median Percent Change in Triglycerides From Baseline to Week 8. |
| NCT00680017 (2) [back to overview] | Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Triglycerides (TG) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 |
| NCT00683618 (15) [back to overview] | 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg |
| NCT00683618 (15) [back to overview] | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 |
| NCT00747149 (1) [back to overview] | Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy |
| NCT00783263 (7) [back to overview] | Number of Participants in Each Stratum Who Reached Their Target LDL-C Level |
| NCT00783263 (7) [back to overview] | Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum |
| NCT00783263 (7) [back to overview] | Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels |
| NCT00783263 (7) [back to overview] | Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment |
| NCT00783263 (7) [back to overview] | Number of Participants Who Reached Their Target LDL-C Level |
| NCT00783263 (7) [back to overview] | Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl |
| NCT00783263 (7) [back to overview] | Number of Participants Who Reached the LDL-C Level of <70 mg/dl |
| NCT00815659 (40) [back to overview] | High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Basal Tumor Necrosis Factor (TNF) Level |
| NCT00815659 (40) [back to overview] | Basal Triglyceride Level |
| NCT00815659 (40) [back to overview] | Basal Total Cholesterol Level |
| NCT00815659 (40) [back to overview] | Basal Small HDL Subfraction Level |
| NCT00815659 (40) [back to overview] | Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Basal LDL-cholesterol Level |
| NCT00815659 (40) [back to overview] | Basal LDL-7 Level |
| NCT00815659 (40) [back to overview] | Basal LDL-5 Level |
| NCT00815659 (40) [back to overview] | Basal LDL-4 Level |
| NCT00815659 (40) [back to overview] | Basal LDL-3 Level |
| NCT00815659 (40) [back to overview] | Basal Intermediate HDL Subfraction Level |
| NCT00815659 (40) [back to overview] | Basal Interleukin 8 (IL-8) Level |
| NCT00815659 (40) [back to overview] | Basal Interleukin 6 (IL-6) Level |
| NCT00815659 (40) [back to overview] | Basal Interleukin 10 (IL-10) Level |
| NCT00815659 (40) [back to overview] | Basal Interleukin 1 (IL-1) Level |
| NCT00815659 (40) [back to overview] | Basal High Sensitivity C-reactive Protein (Hs-CRP) Level |
| NCT00815659 (40) [back to overview] | Basal HDL-cholesterol Level |
| NCT00815659 (40) [back to overview] | LDL-4 Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Triglyceride Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Total Cholesterol Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Number of Patients With Adverse Events |
| NCT00815659 (40) [back to overview] | Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Basal Large HDL Subfraction Level |
| NCT00815659 (40) [back to overview] | Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | LDL-7 Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | LDL-6 Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | LDL-5 Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | LDL-3 Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment |
| NCT00815659 (40) [back to overview] | Basal LDL-6 Level |
| NCT00815659 (40) [back to overview] | Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment |
| NCT00850460 (2) [back to overview] | Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8 |
| NCT00850460 (2) [back to overview] | Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8 |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Triglycerides |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Total Cholesterol (TC) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in TC/HDL-C Ratio |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Non-HDL-C/HDL-C Ratio |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin). |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Apolipoprotein B (Apo B) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Apo B/Apo A-I Ratio |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline Apolipoprotein A-I (Apo A-I) |
| NCT00862251 (18) [back to overview] | Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) |
| NCT00862251 (18) [back to overview] | In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin |
| NCT00862251 (18) [back to overview] | In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) |
| NCT00862251 (18) [back to overview] | In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin |
| NCT00862251 (18) [back to overview] | In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
| NCT00862251 (18) [back to overview] | Percent Change From Baseline in LDL-C/HDL-C Ratio |
| NCT00871351 (5) [back to overview] | Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) |
| NCT00871351 (5) [back to overview] | Percent Change in Total Lipids and Hs-CRP |
| NCT00871351 (5) [back to overview] | Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values |
| NCT00871351 (5) [back to overview] | Percent Change in LDL-C |
| NCT00871351 (5) [back to overview] | Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values |
| NCT00885495 (4) [back to overview] | Cmax of Rosuvastatin |
| NCT00885495 (4) [back to overview] | AUC of Rosuvastatin |
| NCT00885495 (4) [back to overview] | To Investigate the Effect of Rosuvastatin on the Steady State Pharmacokinetics of Darunavir/Ritonavir. |
| NCT00885495 (4) [back to overview] | To Compare the Change in Low-density Lipoprotein (LDL) Cholesterol With Rosuvastatin Therapy Alone, Darunavir/Ritonavir Therapy Alone and With the Co-administration of Rosuvastatin and Darunavir/Ritonavir. |
| NCT00908011 (1) [back to overview] | The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe. |
| NCT00929734 (4) [back to overview] | Relative Change in High-sensitivity C-reactive Protein |
| NCT00929734 (4) [back to overview] | Relative Change in Reactive Hyperemia Index (RHI) |
| NCT00929734 (4) [back to overview] | Relative Change in Interleukin 6 |
| NCT00929734 (4) [back to overview] | Relative Change in FEV1 |
| NCT00979121 (6) [back to overview] | Organ Failure Free Days at Day 14 |
| NCT00979121 (6) [back to overview] | Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14 |
| NCT00979121 (6) [back to overview] | Ventilator Free Days at Study Day 28 |
| NCT00979121 (6) [back to overview] | ICU Free Days to Day 28 |
| NCT00979121 (6) [back to overview] | Hospital Mortality to Day 60. |
| NCT00979121 (6) [back to overview] | Other Secondary Out-comes |
| NCT01011478 (8) [back to overview] | Overall Survival (OS) |
| NCT01011478 (8) [back to overview] | Second Non-colorectal Primary Cancer-free Interval |
| NCT01011478 (8) [back to overview] | Size of Colorectal Adenomas, Including Advanced Adenomas |
| NCT01011478 (8) [back to overview] | Toxicity Assessed by Adverse Events |
| NCT01011478 (8) [back to overview] | Recurrence-free Interval (RFI) |
| NCT01011478 (8) [back to overview] | Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist |
| NCT01011478 (8) [back to overview] | Disease-free Survival |
| NCT01011478 (8) [back to overview] | Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R) |
| NCT01068626 (6) [back to overview] | Change in Visceral Adipose Tissue Area Measured by Computed Tomography. |
| NCT01068626 (6) [back to overview] | Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT. |
| NCT01068626 (6) [back to overview] | Change in Subcutaneous Adipose Tissue Area |
| NCT01068626 (6) [back to overview] | Change in Hepatic Fat Infiltration Measured by CT. |
| NCT01068626 (6) [back to overview] | Change in Body Weight |
| NCT01068626 (6) [back to overview] | Change in LDL |
| NCT01078675 (13) [back to overview] | Total Duration of Exposure |
| NCT01078675 (13) [back to overview] | Adverse Events |
| NCT01078675 (13) [back to overview] | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) |
| NCT01078675 (13) [back to overview] | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 |
| NCT01078675 (13) [back to overview] | Sexual Maturation by Tanner Staging at Baseline |
| NCT01078675 (13) [back to overview] | Sexual Maturation by Tanner Staging at Month 24 |
| NCT01078675 (13) [back to overview] | Percent Change From Baseline in Height |
| NCT01078675 (13) [back to overview] | Sexual Maturation by Tanner Staging at Month 12 |
| NCT01078675 (13) [back to overview] | Overal Treatment Adherence |
| NCT01078675 (13) [back to overview] | Percent Change From Baseline in LDL-C |
| NCT01078675 (13) [back to overview] | Single Dose PK - AUC(0-24) |
| NCT01078675 (13) [back to overview] | Single Dose PK - Cmax |
| NCT01078675 (13) [back to overview] | Single Dose PK - Tmax |
| NCT01105975 (17) [back to overview] | The Number of Episodes of Rashes at Any Time From Baseline Through Week 12 |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Serum Potassium |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Serum Sodium |
| NCT01105975 (17) [back to overview] | Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy |
| NCT01105975 (17) [back to overview] | Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass |
| NCT01105975 (17) [back to overview] | Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State |
| NCT01105975 (17) [back to overview] | Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Total Cholesterol (TC) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apo B (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in TC/HDL-C Ratio (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in TC/HDL-C Ratio (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Total Cholesterol (TC) (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Triglycerides (TG) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Triglycerides (TG) (Phase II) |
| NCT01154036 (28) [back to overview] | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) |
| NCT01154036 (28) [back to overview] | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) |
| NCT01154036 (28) [back to overview] | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) |
| NCT01154036 (28) [back to overview] | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Non-HDL-C (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Non-HDL-C (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apo A-I (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Hs-CRP (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in HDL-C (Phase II) |
| NCT01154036 (28) [back to overview] | Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I) |
| NCT01178853 (1) [back to overview] | Percent Mean Change From Baseline of International Normalized Ratio (INR) |
| NCT01218802 (2) [back to overview] | Carotid IMT |
| NCT01218802 (2) [back to overview] | Bone Mineral Density (BMD) |
| NCT01241903 (1) [back to overview] | Platelet - Leukocyte Aggregates |
| NCT01299038 (1) [back to overview] | Mean Change of Tissue Factor Bearing Microparticles |
| NCT01420549 (1) [back to overview] | Reduction of LDL Cholesterol Levels |
| NCT01544309 (16) [back to overview] | Change From Baseline in 1,5-AG Level |
| NCT01544309 (16) [back to overview] | Change in HbA1c Level |
| NCT01544309 (16) [back to overview] | Percent Change in Non-HDL-C Level |
| NCT01544309 (16) [back to overview] | Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 |
| NCT01544309 (16) [back to overview] | Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) |
| NCT01544309 (16) [back to overview] | Percent Change in Insulin Level |
| NCT01544309 (16) [back to overview] | Percent Change in Blood Glucose Level (Fasting) |
| NCT01544309 (16) [back to overview] | Frequency of Serious Adverse Events (SAE) |
| NCT01544309 (16) [back to overview] | Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level |
| NCT01544309 (16) [back to overview] | Percent Change in 1,5-AG Level |
| NCT01544309 (16) [back to overview] | Change From Baseline in Insulin Level |
| NCT01544309 (16) [back to overview] | Change in Blood Glucose Level (Fasting) |
| NCT01544309 (16) [back to overview] | Change in HbA1c Level |
| NCT01544309 (16) [back to overview] | Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status |
| NCT01544309 (16) [back to overview] | Occurrence of Deterioration of Diabetic Treatment Status |
| NCT01544309 (16) [back to overview] | Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) |
| NCT01567826 (10) [back to overview] | Intravascular Ultrasound (IVUS) Parameters |
| NCT01567826 (10) [back to overview] | Fractional Flow Reserve (FFR) Value |
| NCT01567826 (10) [back to overview] | Blood Chemistry - HsCRP |
| NCT01567826 (10) [back to overview] | Post PCI Cardiac Enzymes |
| NCT01567826 (10) [back to overview] | Lipiscan - Lipid Core Burden Index (LCBI) |
| NCT01567826 (10) [back to overview] | LCBI4mm Max |
| NCT01567826 (10) [back to overview] | Change in LCBI, Lesion |
| NCT01567826 (10) [back to overview] | Change in LCBI4mm Max |
| NCT01567826 (10) [back to overview] | Major Adverse Cardiac Events (MACE) |
| NCT01567826 (10) [back to overview] | Diameter Stenosis |
| NCT01660191 (6) [back to overview] | Changes to Glucose Metabolism - Fructosamine |
| NCT01660191 (6) [back to overview] | Changes in Major Lipid Parameters - VLDL Size |
| NCT01660191 (6) [back to overview] | Changes to Glucose Metabolism - HbA1c and Insulin |
| NCT01660191 (6) [back to overview] | Changes in Plasma CoQ10 Levels |
| NCT01660191 (6) [back to overview] | Changes HDL Particle Number and LDL Particle Number |
| NCT01660191 (6) [back to overview] | Changes in HDL and LDL Size |
| NCT01702987 (1) [back to overview] | Phosphocreatine Recovery |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL--C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percentage of Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Non-High -Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
| NCT01709500 (25) [back to overview] | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
| NCT01730040 (24) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
| NCT01730053 (24) [back to overview] | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
| NCT01763866 (22) [back to overview] | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 |
| NCT01763866 (22) [back to overview] | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Triglycerides at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Non-HDL-C at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Lipoprotein(a) at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in HDL-C at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B at Week 12 |
| NCT01763866 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 |
| NCT01763866 (22) [back to overview] | Change From Baseline in LDL-C at Week 12 |
| NCT01763866 (22) [back to overview] | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 |
| NCT01795937 (10) [back to overview] | Cmax,ss of Faldaprevir (Statins Part) |
| NCT01795937 (10) [back to overview] | Cmax,ss (Itraconazole Part) |
| NCT01795937 (10) [back to overview] | Cmax of Rosuvastatin |
| NCT01795937 (10) [back to overview] | Cmax of Atorvastatin (Statins Part) |
| NCT01795937 (10) [back to overview] | AUCÏ„,ss of Faldaprevir (Statins Part) |
| NCT01795937 (10) [back to overview] | AUCÏ„,ss (Itraconazole Part) |
| NCT01795937 (10) [back to overview] | AUC0-tz of Rosuvastatin |
| NCT01795937 (10) [back to overview] | AUC0-tz of Atorvastatin |
| NCT01795937 (10) [back to overview] | AUC0-∞ of Rosuvastatin (Statins Part) |
| NCT01795937 (10) [back to overview] | AUC0-∞ of Atorvastatin (Statins Part) |
| NCT01813357 (2) [back to overview] | Progression of Carotid Intima Media Thickness |
| NCT01813357 (2) [back to overview] | Rates of Adverse Events |
| NCT01837823 (15) [back to overview] | Mechanism of Reverse Cholesterol Transport |
| NCT01837823 (15) [back to overview] | MACE |
| NCT01837823 (15) [back to overview] | Lesion LCBI |
| NCT01837823 (15) [back to overview] | LCBI 4mm at Same Anatomical Site |
| NCT01837823 (15) [back to overview] | Fibrous Cap Thickness (FCT) by OCT |
| NCT01837823 (15) [back to overview] | Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max |
| NCT01837823 (15) [back to overview] | Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP |
| NCT01837823 (15) [back to overview] | Correlation Between Plaque Morphology and HDL Functionality |
| NCT01837823 (15) [back to overview] | Change in Atheroma Volume |
| NCT01837823 (15) [back to overview] | Plaque Morphology as Related to Haptoglobin |
| NCT01837823 (15) [back to overview] | MACE |
| NCT01837823 (15) [back to overview] | IVUS Imaging Measures |
| NCT01837823 (15) [back to overview] | Inflammatory and Lipid Parameters |
| NCT01837823 (15) [back to overview] | Biomarker Release |
| NCT01837823 (15) [back to overview] | Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max) |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C |
| NCT01890967 (10) [back to overview] | Number of Participants With an Injection Site Reaction |
| NCT01890967 (10) [back to overview] | Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) |
| NCT01890967 (10) [back to overview] | Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in Lipoprotein(a) [Lp(a)] |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels |
| NCT01890967 (10) [back to overview] | Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014 |
| NCT01890967 (10) [back to overview] | Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B) |
| NCT01918332 (2) [back to overview] | sitDBP Changes at Week 8 From Baseline |
| NCT01918332 (2) [back to overview] | LDL-C Percentage Changes at Week 8 From Baseline |
| NCT02114697 (2) [back to overview] | Plaque Volume of Carotid Arteries |
| NCT02114697 (2) [back to overview] | Plaque Volume of Carotid Arteries |
| NCT02226198 (32) [back to overview] | TC (mg/dL) |
| NCT02226198 (32) [back to overview] | Non-HDL C/HDL C |
| NCT02226198 (32) [back to overview] | Non-HDL C (mmol/L) |
| NCT02226198 (32) [back to overview] | Non-HDL C (mg/dL) |
| NCT02226198 (32) [back to overview] | HDL-C (mmol/L) |
| NCT02226198 (32) [back to overview] | Weight |
| NCT02226198 (32) [back to overview] | Urinalysis Abnormalitites |
| NCT02226198 (32) [back to overview] | Tanner Stage |
| NCT02226198 (32) [back to overview] | Physical Exam Abnormalitites |
| NCT02226198 (32) [back to overview] | TG (mmol/L) |
| NCT02226198 (32) [back to overview] | LDL-Cholesterol (mmol/L) |
| NCT02226198 (32) [back to overview] | LDL-Cholesterol (mg/dL) |
| NCT02226198 (32) [back to overview] | LDL-C, Not on Apheresis (mmol/L) |
| NCT02226198 (32) [back to overview] | LDL-C, Not on Apheresis (mg/dL) |
| NCT02226198 (32) [back to overview] | Abnormal Vital Signs |
| NCT02226198 (32) [back to overview] | AE's Leading to Discontinuation |
| NCT02226198 (32) [back to overview] | ApoB (g/L) |
| NCT02226198 (32) [back to overview] | ApoB (mg/dL) |
| NCT02226198 (32) [back to overview] | ApoB/ApoA |
| NCT02226198 (32) [back to overview] | ECG Abnormalities |
| NCT02226198 (32) [back to overview] | LDL C/HDL C |
| NCT02226198 (32) [back to overview] | HDL-C (mg/dL) |
| NCT02226198 (32) [back to overview] | LDL-C From End of Placebo (mmol/L) |
| NCT02226198 (32) [back to overview] | LDL-C From End of Placebo (mg/dL) |
| NCT02226198 (32) [back to overview] | Height Z-score |
| NCT02226198 (32) [back to overview] | Height |
| NCT02226198 (32) [back to overview] | Adverse Events |
| NCT02226198 (32) [back to overview] | Abnormal Serum Levels |
| NCT02226198 (32) [back to overview] | Trough Concentrations |
| NCT02226198 (32) [back to overview] | TG (mg/dL) |
| NCT02226198 (32) [back to overview] | TC/HDL C |
| NCT02226198 (32) [back to overview] | TC (mmol/L) |
| NCT02317016 (14) [back to overview] | "Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time t (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291" |
| NCT02317016 (14) [back to overview] | Assessment of Minimum Plasma Concentration at Steady State (Css,Min) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of the Metabolite to Parent Ratios of AUCtau (MRAUCtau) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of the Metabolite to Parent Ratios of Css,Max (MRCss,Max) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291 |
| NCT02317016 (14) [back to overview] | Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUCtau) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02317016 (14) [back to overview] | Assessment of Maximum Plasma Concentration at Steady State (Css,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together |
| NCT02401256 (1) [back to overview] | Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Vital Signs |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Growth, Height |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities |
| NCT02434497 (56) [back to overview] | Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg |
| NCT02434497 (56) [back to overview] | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | The Number of Participants Who Experianced Adverse Events and Serious Adverse Events |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN |
| NCT02434497 (56) [back to overview] | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Growth, Weight |
| NCT02434497 (56) [back to overview] | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) |
| NCT02476006 (11) [back to overview] | Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use |
| NCT02476006 (11) [back to overview] | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT02476006 (11) [back to overview] | Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections |
| NCT02476006 (11) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12 |
| NCT02476006 (11) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12 |
| NCT02476006 (11) [back to overview] | Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 |
| NCT02476006 (11) [back to overview] | Percent Change From Baseline in Triglycerides at Week 12 |
| NCT02476006 (11) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12 |
| NCT02476006 (11) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 |
| NCT02476006 (11) [back to overview] | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 |
| NCT02476006 (11) [back to overview] | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
| NCT02546323 (7) [back to overview] | Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average |
| NCT02546323 (7) [back to overview] | Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period |
| NCT02546323 (7) [back to overview] | Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA |
| NCT02546323 (7) [back to overview] | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb |
| NCT02546323 (7) [back to overview] | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA |
| NCT02546323 (7) [back to overview] | Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA |
| NCT02546323 (7) [back to overview] | Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF) |
| NCT02574845 (3) [back to overview] | Maximum Concentration of Rosuvastatin (Cmax) |
| NCT02574845 (3) [back to overview] | Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz) |
| NCT02574845 (3) [back to overview] | Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞) |
| NCT02586155 (15) [back to overview] | Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Incidence of All-cause Mortality |
| NCT02586155 (15) [back to overview] | Incidence of Hospitalization for Congestive Heart Failure (CHF) |
| NCT02586155 (15) [back to overview] | Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE |
| NCT02586155 (15) [back to overview] | Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2) |
| NCT02586155 (15) [back to overview] | Change in Glucose From Baseline Over Time Between and Within Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups |
| NCT02586155 (15) [back to overview] | Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE |
| NCT02586155 (15) [back to overview] | Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE |
| NCT02704702 (3) [back to overview] | Area Under the Concentration-time Curve |
| NCT02704702 (3) [back to overview] | Maximum Observed Concentration |
| NCT02704702 (3) [back to overview] | Time to Reach Maximum Observed Plasma Concentration |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis |
| NCT02715726 (22) [back to overview] | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience at Least 1 Adverse Event (AE) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience 1 or More Hepatitis-related AEs |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience 1 or More Gallbladder-related AEs |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) |
| NCT02741245 (19) [back to overview] | Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event |
| NCT02741245 (19) [back to overview] | Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) |
| NCT02741245 (19) [back to overview] | Percentage of Participants With Potential Hy's Law Condition |
| NCT02748057 (3) [back to overview] | Percentage of Participants Who Had Study Drug Discontinued Due to an AE |
| NCT02748057 (3) [back to overview] | Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) |
| NCT02748057 (3) [back to overview] | Percentage of Participants Who Experience at Least 1 Adverse Event (AE) |
| NCT02841774 (2) [back to overview] | Treatment-emergent Adverse Events |
| NCT02841774 (2) [back to overview] | Mean Percent Change in Fasting LDL-cholesterol |
| NCT02854527 (12) [back to overview] | Maximum Concentration of Rosuvastatin (Cmax) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Metformin From 0 Extrapolated to Infinity (AUC 0-∞) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Metformin From 0 to Last Quantifiable Data Point (AUC 0-tz) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞) |
| NCT02854527 (12) [back to overview] | Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz) |
| NCT02854527 (12) [back to overview] | Maximum Concentration of Digoxin (Cmax) |
| NCT02854527 (12) [back to overview] | Maximum Concentration of Furosemide (Cmax) |
| NCT02854527 (12) [back to overview] | Maximum Concentration of Metformin (Cmax) |
| NCT02901067 (10) [back to overview] | Pulmonary Embolism |
| NCT02901067 (10) [back to overview] | Ventilator Free Days |
| NCT02901067 (10) [back to overview] | All-cause Mortality |
| NCT02901067 (10) [back to overview] | Incidence of Acute Lung Injury (ALI) |
| NCT02901067 (10) [back to overview] | Intensive Care Unit (ICU) Days |
| NCT02901067 (10) [back to overview] | Incidence of Arterial Thrombotic Complications: Myocardial Infarction (MI) and Cerebrovascular Accident (CVA). |
| NCT02901067 (10) [back to overview] | Incidence of Multiple Organ Failure (MOF) |
| NCT02901067 (10) [back to overview] | Fibrinolysis Phenotypes |
| NCT02901067 (10) [back to overview] | Incidence of VTE |
| NCT02901067 (10) [back to overview] | Incidence of Venous Thromboembolism (VTE) |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Lipoprotein (a) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Fasting Triglycerides at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Lumen Volume at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Total Cholesterol at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Apolipoprotein A-1 at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Total Cholesterol (TC) at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Apolipoprotein B at Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in External Elastic Membrane Volume at Week 36 |
| NCT02984982 (24) [back to overview] | Number of Participants With Cardiovascular (CV) Adverse Events |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36 |
| NCT02984982 (24) [back to overview] | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Lumen Volume at Week 36 |
| NCT02984982 (24) [back to overview] | Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36 |
| NCT03011775 (17) [back to overview] | Safety and Tolerability 4 |
| NCT03011775 (17) [back to overview] | Lipid Metabolism 3 |
| NCT03011775 (17) [back to overview] | Percutaneous Coronary Intervention [Coronary Revascularization] |
| NCT03011775 (17) [back to overview] | Cardiovascular Hospitalization |
| NCT03011775 (17) [back to overview] | Level of Insulin Resistance 2 |
| NCT03011775 (17) [back to overview] | Lipid Metabolism 1 |
| NCT03011775 (17) [back to overview] | Lipid Metabolism 2 |
| NCT03011775 (17) [back to overview] | Carotic Atherosclerotic Lesions |
| NCT03011775 (17) [back to overview] | Сardiovascular Death |
| NCT03011775 (17) [back to overview] | Coronary Artery Bypass [Coronary Revascularization] |
| NCT03011775 (17) [back to overview] | Systemic Inflammation Level |
| NCT03011775 (17) [back to overview] | Safety and Tolerability 3 |
| NCT03011775 (17) [back to overview] | Safety and Tolerability 2 |
| NCT03011775 (17) [back to overview] | Safety and Tolerability 1 |
| NCT03011775 (17) [back to overview] | Thickness of the Intima-media Complex |
| NCT03011775 (17) [back to overview] | Level of Insulin Resistance 1 |
| NCT03011775 (17) [back to overview] | Diameter of Stenosis [Carotic Atherosclerotic Lesions] |
| NCT03019549 (3) [back to overview] | Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCÏ„) of Lanabecestat (LY3314814) |
| NCT03019549 (3) [back to overview] | Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin |
| NCT03019549 (3) [back to overview] | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat |
| NCT03074630 (7) [back to overview] | Change in Plasma LDL Cholesterol |
| NCT03074630 (7) [back to overview] | Change in Plasma HDL Cholesterol |
| NCT03074630 (7) [back to overview] | Change in Plasma FFA |
| NCT03074630 (7) [back to overview] | Change in Peripheral Insulin Sensitivity |
| NCT03074630 (7) [back to overview] | Urinary Glucose Excretion |
| NCT03074630 (7) [back to overview] | Change in Total Cholesterol |
| NCT03074630 (7) [back to overview] | Change in Plasma Triglycerides |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T4 vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Cimetidine + R1 (T3) vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Probenecid + R1 (T4) vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Rifampin + R1 (T2) vs. R1) |
| NCT03307252 (12) [back to overview] | Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T4 vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Verapamil + R1 (T1) vs. R1) |
| NCT03307252 (12) [back to overview] | Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T1 vs. R1) |
| NCT03307252 (12) [back to overview] | Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T2 vs. R1) |
| NCT03307252 (12) [back to overview] | Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T3 vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T1 vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T2 vs. R1) |
| NCT03307252 (12) [back to overview] | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T3 vs. R1) |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on AUC0-last Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on Tmax Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on Cmax Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on t1/2 Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on AUC0-inf Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on CL/F Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on AUC0-24 Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Area Under the Plasma Concentration-time Curve From Time 0 to Last (AUC0-last) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Apparent Volume of Distribution During the Terminal Phase (Vz/F) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Apparent Plasma Terminal Half-life (t1/2) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Apparent Clearance After Extravascular Administration (CL/F) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on Vz/F Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Effect of Rifampin on C24 Post-dose Period 2 |
| NCT03311841 (18) [back to overview] | Time to Maximum Plasma Concentration (Tmax) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Plasma Concentration at 24 Hours (C24) Post-dose Period 1 |
| NCT03311841 (18) [back to overview] | Maximum Plasma Concentration (Cmax) Post-dose Period 1 |
| NCT03415178 (21) [back to overview] | Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period |
| NCT03415178 (21) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period |
| NCT03415178 (21) [back to overview] | Percentage of Participants With a SYDNEY or Current Auto-Injector (AI)-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Supervised Injections on Week 0 (Day 1): Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period |
| NCT03415178 (21) [back to overview] | Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period |
| NCT03415178 (21) [back to overview] | Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period |
| NCT03415178 (21) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab : Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab: Single-Arm Period |
| NCT03415178 (21) [back to overview] | Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period |
| NCT03415178 (21) [back to overview] | Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period |
| NCT03415178 (21) [back to overview] | Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Single-Arm Period |
| NCT03415178 (21) [back to overview] | Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period |
| NCT03415178 (21) [back to overview] | Injection Experience Questionnaire at Initial Supervised Injection: Overall Ease of Use Scores: Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Injection-Treatment Acceptance Questionnaire (I-TAQ©) After Last Injection (at Week 12) - Overall Acceptance Scores: Single-Arm Period |
| NCT03415178 (21) [back to overview] | Maximum Serum Alirocumab Concentration Observed - Cmax : Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Maximum Serum Alirocumab Concentration Observed - Cmax : Single-Arm Period |
| NCT03415178 (21) [back to overview] | Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response: Parallel-Arm Period |
| NCT03415178 (21) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4: Parallel-Arm Period |
| NCT03510715 (13) [back to overview] | Percentage of Participants Reporting >=15 Percent (%) Reduction in LDL-C Level at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Lipoprotein a (Lp) (a) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Total Cholesterol (Total-C) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 12, 24 and 48 - ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Weeks 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Number of Participants With Tanner Staging at Baseline, Weeks 12, 24 and 48 |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Apolipoprotein (Apo) B at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Absolute Change From Baseline in LDL-C Level at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12: Intent-to-Treat (ITT) Analysis |
| NCT03510715 (13) [back to overview] | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12: On-treatment Analysis |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein A1 at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Total Cholesterol at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level <130 mg/dL (3.37 mmol/L) at Week 12: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level Lower Than (<) 130 mg/dL (3.37 mmol/L) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: ITT Estimand |
| NCT03510884 (44) [back to overview] | OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104 |
| NCT03510884 (44) [back to overview] | DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Total Cholesterol at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Week 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104 |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 130 mg/dL (3.37 mmol/L) at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 110 mg/dL (2.84 mmol/L) at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Who Achieved at Least 30 Percent (%) Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percentage of Participants Achieved at Least 30% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein A1 at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Weeks 12, and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Lipoprotein (a) at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Fasting Triglycerides at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Percent Change From Baseline in Apolipoprotein B at Weeks 12 and 24: On-treatment Estimand |
| NCT03510884 (44) [back to overview] | DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response |
| NCT03510884 (44) [back to overview] | DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response |
| NCT03510884 (44) [back to overview] | DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Furosemide) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Furosemide) |
| NCT04590937 (12) [back to overview] | Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax, Rosuvastatin) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Digoxin) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Digoxin) |
| NCT04590937 (12) [back to overview] | Maximum Measured Concentration of Digoxin in Plasma (Cmax, Digoxin) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Rosuvastatin) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Metformin) |
| NCT04590937 (12) [back to overview] | Maximum Measured Concentration of Furosemide in Plasma (Cmax, Furosemide) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Metformin) |
| NCT04590937 (12) [back to overview] | Maximum Measured Concentration of Metformin in Plasma (Cmax, Metformin) |
| NCT04590937 (12) [back to overview] | Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Rosuvastatin) |
| NCT04608344 (8) [back to overview] | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
| NCT04608344 (8) [back to overview] | PK Parameter: Cmax of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | PK Parameter: Cmax of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | PK Parameter: AUCinf of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | PK Parameter: AUCinf of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS |
| NCT04608344 (8) [back to overview] | Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities |
| NCT04621227 (9) [back to overview] | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality) |
| NCT04621227 (9) [back to overview] | Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9) |
| NCT04621227 (9) [back to overview] | Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7 |
| NCT04621227 (9) [back to overview] | AUClast of Midazolam in Periods 2, 5 and 8 |
| NCT04621227 (9) [back to overview] | Change From Baseline in Body Weight |
| NCT04621227 (9) [back to overview] | Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria |
| NCT04621227 (9) [back to overview] | Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) |
| NCT04621227 (9) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
| NCT04621227 (9) [back to overview] | Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria |
| NCT04846231 (4) [back to overview] | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. |
| NCT04846231 (4) [back to overview] | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. |
| NCT04846231 (4) [back to overview] | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. |
| NCT04846231 (4) [back to overview] | Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. |
| NCT05045638 (7) [back to overview] | AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin |
| NCT05045638 (7) [back to overview] | AUCinf of Sotorasib |
| NCT05045638 (7) [back to overview] | AUClast of Sotorasib |
| NCT05045638 (7) [back to overview] | Cmax of Sotorasib |
| NCT05045638 (7) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin |
| NCT05045638 (7) [back to overview] | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin |
| NCT05045638 (7) [back to overview] | Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs) |
Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)
Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded (NCT00127218)
Timeframe: 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Any Statin Plus Niacin | 6 |
| Any Statin Plus Placebo | 2 |
Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries
The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries. (NCT00127218)
Timeframe: 18 months
| Intervention | percentage of internal carotid artery (Mean) |
|---|
| Niacin Plus Statin | 7 |
| Placebo Plus Statin | 5 |
Time to Bone Fracture
Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: Up to 5 years
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 1662.7 |
| Placebo | 1546.9 |
Time to Death Due to Any Cause
Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: up to 5 years
| Intervention | days (Mean) |
|---|
| Rosuvastatin | 1543.3 |
| Placebo | 1619.1 |
Time to Development of Diabetes Mellitus
Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: up to 5 years
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 1687.0 |
| Placebo | 1517.0 |
Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)
Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: up to 5 years
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 1646.4 |
| Placebo | 1578.3 |
Time to Non-cardiovascular Death
Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: up to 5 years
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 1558.5 |
| Placebo | 1640.5 |
Time to Venous Thromboembolic Event
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean (NCT00239681)
Timeframe: up to 5 years
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 1147.4 |
| Placebo | 1377.2 |
Number of Randomised Participants That Died From Cardiovascular Cause
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 324 |
| Placebo | 324 |
Number of Randomised Participants That Died From Any Cause.
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 636 |
| Placebo | 660 |
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 148 |
| Placebo | 152 |
Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 390 |
| Placebo | 360 |
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 396 |
| Placebo | 408 |
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 614 |
| Placebo | 645 |
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
(NCT00240331)
Timeframe: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10mg | 258 |
| Placebo | 256 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.02947 |
| Atorvastatin | 0.27198 |
| All Treatment | 0.08787 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16587 |
| Atorvastatin | 0.18469 |
| All Treatment | 0.18832 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.05397 |
| Atorvastatin | 0.29486 |
| All Treatment | 0.11079 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.07846 |
| Atorvastatin | 0.13910 |
| All Treatment | -0.02825 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.00600 |
| Atorvastatin | 0.22710 |
| All Treatment | 0.03684 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.15859 |
| Atorvastatin | 0.13133 |
| All Treatment | 0.15516 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.02276 |
| Atorvastatin | 0.21405 |
| All Treatment | 0.04578 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16111 |
| Atorvastatin | 0.26194 |
| All Treatment | 0.18918 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.15614 |
| Atorvastatin | 0.06987 |
| All Treatment | 0.14226 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04510 |
| Atorvastatin | 0.16280 |
| All Treatment | 0.06739 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.13689 |
| Atorvastatin | 0.12931 |
| All Treatment | -0.08108 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.02775 |
| Atorvastatin | 0.06535 |
| All Treatment | -0.01569 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.08588 |
| Atorvastatin | 0.18570 |
| All Treatment | -0.02491 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.12068 |
| Atorvastatin | 0.15929 |
| All Treatment | -0.05186 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.02594 |
| Atorvastatin | 0.24018 |
| All Treatment | 0.07381 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.16755 |
| Atorvastatin | 0.08891 |
| All Treatment | -0.11221 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.06085 |
| Atorvastatin | 0.12507 |
| All Treatment | -0.02841 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.13572 |
| Atorvastatin | 0.07339 |
| All Treatment | -0.08855 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.05945 |
| Atorvastatin | 0.12132 |
| All Treatment | -0.02666 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.05251 |
| Atorvastatin | 0.11755 |
| All Treatment | 0.01345 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.14569 |
| Atorvastatin | 0.04948 |
| All Treatment | -0.08471 |
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: Assessed at 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.07019 |
| Atorvastatin | 0.26855 |
| All Treatment | 0.12013 |
Urinary Albumin/Creatinine Ratio at Week 26
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio. (NCT00296374)
Timeframe: Assessed at Week 26
| Intervention | mg/g (Geometric Mean) |
|---|
| Rosuvastatin 10mg | 0.927 |
| Rosuvastatin 40mg | 0.913 |
| Atorvastatin 80mg | 0.831 |
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio. (NCT00296374)
Timeframe: Assessed at Week 52 LOCF
| Intervention | mg/g (Geometric Mean) |
|---|
| Rosuvastatin 10mg | 1.016 |
| Rosuvastatin 40mg | 0.836 |
| Atorvastatin 80mg | 0.823 |
Urinary Protein/Creatinine Ratio at Week 26.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio. (NCT00296374)
Timeframe: Assessed at Week 26
| Intervention | mg/g (Geometric Mean) |
|---|
| Rosuvastatin 10mg | 1.007 |
| Rosuvastatin 40mg | 0.994 |
| Atorvastatin 80mg | 0.876 |
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio. (NCT00296374)
Timeframe: Assessed at Week 52, Last observation carried forward (LOCF)
| Intervention | mg/g (Geometric Mean) |
|---|
| Rosuvastatin 10mg | 1.016 |
| Rosuvastatin 40mg | 0.955 |
| Atorvastatin 80mg | 0.874 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14758 |
| Atorvastatin | 0.26805 |
| All Treatment | 0.17550 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08593 |
| Atorvastatin | 0.00032 |
| All Treatment | 0.06930 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04760 |
| Atorvastatin | 0.25636 |
| All Treatment | 0.07766 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.05906 |
| Atorvastatin | 0.13706 |
| All Treatment | -0.01775 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.10997 |
| Atorvastatin | 0.30537 |
| All Treatment | 0.15652 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.00569 |
| Atorvastatin | 0.20008 |
| All Treatment | 0.04833 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16085 |
| Atorvastatin | 0.15933 |
| All Treatment | 0.17306 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14207 |
| Atorvastatin | 0.11171 |
| All Treatment | 0.13429 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.24494 |
| Atorvastatin | -0.07059 |
| All Treatment | -0.15586 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.10533 |
| Atorvastatin | -0.00604 |
| All Treatment | -0.09437 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.26268 |
| Atorvastatin | -0.08593 |
| All Treatment | -0.23226 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.05426 |
| Atorvastatin | -0.01643 |
| All Treatment | -0.04256 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.13489 |
| Atorvastatin | -0.18105 |
| All Treatment | -0.14690 |
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.01586 |
| Atorvastatin | -0.03124 |
| All Treatment | 0.00101 |
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.26802 |
| Atorvastatin | -0.11804 |
| All Treatment | -0.24204 |
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.06356 |
| Atorvastatin | -0.04402 |
| All Treatment | -0.05499 |
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.17729 |
| Atorvastatin | -0.19501 |
| All Treatment | -0.17911 |
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.01709 |
| Atorvastatin | -0.05610 |
| All Treatment | -0.02569 |
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.19850 |
| Atorvastatin | -0.06481 |
| All Treatment | -0.17579 |
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.01040 |
| Atorvastatin | 0.00241 |
| All Treatment | 0.00189 |
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.11072 |
| Atorvastatin | -0.12835 |
| All Treatment | -0.11378 |
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.03010 |
| Atorvastatin | -0.00944 |
| All Treatment | 0.02609 |
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14457 |
| Atorvastatin | -0.15546 |
| All Treatment | 0.08841 |
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.11373 |
| Atorvastatin | 0.01123 |
| All Treatment | 0.07576 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08146 |
| Atorvastatin | 0.05333 |
| All Treatment | 0.05845 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.06694 |
| Atorvastatin | 0.17296 |
| All Treatment | -0.01144 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.09189 |
| Atorvastatin | 0.33769 |
| All Treatment | 0.14988 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.04088 |
| Atorvastatin | 0.06598 |
| All Treatment | -0.01652 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.15146 |
| Atorvastatin | 0.04886 |
| All Treatment | -0.12168 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.01427 |
| Atorvastatin | 0.08821 |
| All Treatment | 0.00737 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.17909 |
| Atorvastatin | 0.08090 |
| All Treatment | 0.12787 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.08468 |
| Atorvastatin | 0.12805 |
| All Treatment | -0.04102 |
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF). (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.03507 |
| Atorvastatin | 0.14258 |
| All Treatment | 0.01600 |
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
(NCT00296374)
Timeframe: Assessed at Baseline and Week 26
| Intervention | mL/min (Mean) |
|---|
| Rosuvastatin 10mg | -2.73 |
| Rosuvastatin 40mg | -5.46 |
| Atorvastatin 80mg | -1.78 |
Change From Baseline in eGFR at Week 52 [LOCF]
(NCT00296374)
Timeframe: Assessed at Baseline and Week 52 [LOCF]
| Intervention | mL/min (Mean) |
|---|
| Rosuvastatin 10 mg | -3.70 |
| Rosuvastatin 40 mg | -7.29 |
| Atorvastatin 80 mg | -1.61 |
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.26146 |
| Atorvastatin | 0.05248 |
| All Treatment | -0.22109 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.01528 |
| Atorvastatin | 0.21198 |
| All Treatment | 0.05251 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.00642 |
| Atorvastatin | 0.14331 |
| All Treatment | 0.04311 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.13220 |
| Atorvastatin | 0.35715 |
| All Treatment | 0.18971 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.03476 |
| Atorvastatin | 0.10902 |
| All Treatment | 0.04508 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.04785 |
| Atorvastatin | 0.11256 |
| All Treatment | -0.01362 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.01798 |
| Atorvastatin | 0.20127 |
| All Treatment | 0.05369 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.07271 |
| Atorvastatin | 0.08654 |
| All Treatment | -0.02876 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.08211 |
| Atorvastatin | 0.16654 |
| All Treatment | -0.03001 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (NCT00296374)
Timeframe: 52 Weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.10037 |
| Atorvastatin | 0.21205 |
| All Treatment | 0.12270 |
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (NCT00296374)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.05514 |
| Atorvastatin | 0.19842 |
| All Treatment | 0.00038 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.10258 |
| Atorvastatin | 0.13505 |
| All Treatments | 0.11103 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08108 |
| Atorvastatin | -0.16753 |
| All Treatments | 0.00479 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.23547 |
| Atorvastatin | 0.25043 |
| All Treatments | 0.25208 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.17479 |
| Atorvastatin | 0.18677 |
| All Treatments | 0.18203 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14783 |
| Atorvastatin | 0.21561 |
| All Treatments | 0.16899 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20285 |
| Atorvastatin | -0.13565 |
| All Treatments | 0.12568 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.05037 |
| Atorvastatin | 0.09779 |
| All Treatments | 0.05936 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.10365 |
| Atorvastatin | -0.24717 |
| All Treatments | 0.01386 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16080 |
| Atorvastatin | 0.17150 |
| All Treatments | 0.16578 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.24107 |
| Atorvastatin | -0.08640 |
| All Treatments | 0.16525 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04955 |
| Atorvastatin | 0.02740 |
| All Treatments | 0.03798 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.11997 |
| Atorvastatin | -0.21073 |
| All Treatments | 0.03955 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.18188 |
| Atorvastatin | 0.17503 |
| All Treatments | 0.18566 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.23734 |
| Atorvastatin | 0.01311 |
| All Treatments | 0.17958 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.02506 |
| Atorvastatin | 0.02201 |
| All Treatments | 0.01860 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08954 |
| Atorvastatin | -0.20870 |
| All Treatments | 0.01926 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.11526 |
| Atorvastatin | -0.06890 |
| All Treatments | 0.07248 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.21730 |
| Atorvastatin | 0.21151 |
| All Treatments | 0.21477 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.19626 |
| Atorvastatin | 0.09835 |
| All Treatments | 0.18349 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.18473 |
| Atorvastatin | -0.02690 |
| All Treatments | 0.12496 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.10698 |
| Atorvastatin | 0.13814 |
| All Treatments | 0.11414 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.05859 |
| Atorvastatin | -0.12938 |
| All Treatments | -0.00540 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.12595 |
| Atorvastatin | 0.05628 |
| All Treatments | 0.13754 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.18504 |
| Atorvastatin | 0.17259 |
| All Treatments | 0.19146 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20346 |
| Atorvastatin | 0.18041 |
| All Treatments | 0.20818 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.18055 |
| Atorvastatin | 0.24987 |
| All Treatments | 0.22094 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.05881 |
| Atorvastatin | -0.20262 |
| All Treatments | -0.01340 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14302 |
| Atorvastatin | 0.24393 |
| All Treatments | 0.17632 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26
"Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.~)" (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16206 |
| Atorvastatin | 0.20032 |
| All Treatments | 0.17628 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20386 |
| Atorvastatin | -0.04698 |
| All Treatments | 0.14495 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.06794 |
| Atorvastatin | 0.05410 |
| All Treatments | 0.05465 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.07188 |
| Atorvastatin | -0.16669 |
| All Treatments | 0.00955 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04652 |
| Atorvastatin | 0.06344 |
| All Treatments | 0.04149 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.03957 |
| Atorvastatin | -0.17644 |
| All Treatments | -0.01549 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20659 |
| Atorvastatin | 0.23989 |
| All Treatments | 0.21728 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.17601 |
| Atorvastatin | 0.21701 |
| All Treatments | 0.19643 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20462 |
| Atorvastatin | 0.03480 |
| All Treatments | 0.16077 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.15348 |
| Atorvastatin | -0.06049 |
| All Treatments | 0.10089 |
Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16868 |
| Atorvastatin | -0.09428 |
| All Treatments | 0.10679 |
Urinary Albumin/Creatinine Ratio at Week 26
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio. (NCT00296400)
Timeframe: Assessed at baseline and Week 26
| Intervention | ratio (Geometric Mean) |
|---|
| Rosuvastatin 10 mg | 0.850 |
| Rosuvastatin 40 mg | 0.946 |
| Atorvastatin 80 mg | 0.731 |
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio. (NCT00296400)
Timeframe: Assessed at baseline and Week 52 [LOCF]
| Intervention | ratio (Geometric Mean) |
|---|
| Rosuvastatin 10 mg | 0.879 |
| Rosuvastatin 40 mg | 0.967 |
| Atorvastatin 80 mg | 0.719 |
Urinary Protein/Creatinine Ratio at Week 26.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio. (NCT00296400)
Timeframe: Assessed at baseline and Week 26
| Intervention | ratio (Geometric Mean) |
|---|
| Rosuvastatin 10 mg | 0.932 |
| Rosuvastatin 40 mg | 1.057 |
| Atorvastatin 80 mg | 0.762 |
Urinary Protein/Creatinine Ratio at Week 52 [LOCF]
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio. (NCT00296400)
Timeframe: Assessed at baseline and Week 52 (LOCF)
| Intervention | ratio (Geometric Mean) |
|---|
| Rosuvastatin 10 mg | 0.938 |
| Rosuvastatin 40 mg | 1.082 |
| Atorvastatin 80 mg | 0.759 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04160 |
| Atorvastatin | 0.00531 |
| All Treatments | 0.03430 |
Change From Baseline in eGFR at Week 52 [LOCF]
The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value. (NCT00296400)
Timeframe: Assessed at baseline and Week 52 [LOCF]
| Intervention | mL/min (Mean) |
|---|
| Rosuvastatin 10 mg | -2.71 |
| Rosuvastatin 40 mg | -3.30 |
| Atorvastatin 80 mg | -1.74 |
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value. (NCT00296400)
Timeframe: Assessed at baseline and Week 26
| Intervention | mL/min (Mean) |
|---|
| Rosuvastatin 10 mg | 1.39 |
| Rosuvastatin 40 mg | -3.41 |
| Atorvastatin 80 mg | -1.61 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.13029 |
| Atorvastatin | 0.17554 |
| All Treatments | 0.14191 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.11047 |
| Atorvastatin | 0.07751 |
| All Treatments | 0.08580 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.06098 |
| Atorvastatin | -0.03181 |
| All Treatments | 0.03861 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.11217 |
| Atorvastatin | 0.11006 |
| All Treatments | -0.03932 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.02907 |
| Atorvastatin | -0.09476 |
| All Treatments | -0.00160 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.15415 |
| Atorvastatin | 0.10486 |
| All Treatments | -0.06121 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.04858 |
| Atorvastatin | -0.05535 |
| All Treatments | 0.02023 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.20805 |
| Atorvastatin | 0.18299 |
| All Treatments | -0.07681 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.06029 |
| Atorvastatin | -0.08151 |
| All Treatments | 0.02283 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.19532 |
| Atorvastatin | 0.14967 |
| All Treatments | -0.09001 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08263 |
| Atorvastatin | -0.06860 |
| All Treatments | 0.04337 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.23887 |
| Atorvastatin | 0.17170 |
| All Treatments | -0.10817 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.08194 |
| Atorvastatin | -0.06576 |
| All Treatments | 0.04477 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.23597 |
| Atorvastatin | 0.19933 |
| All Treatments | -0.10205 |
Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.12643 |
| Atorvastatin | 0.00486 |
| All Treatments | -0.08301 |
Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.06383 |
| Atorvastatin | 0.12687 |
| All Treatments | 0.07462 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.01684 |
| Atorvastatin | 0.01755 |
| All Treatments | 0.01758 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.14080 |
| Atorvastatin | 0.02750 |
| All Treatments | 0.09472 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.02679 |
| Atorvastatin | -0.07603 |
| All Treatments | -0.00171 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.15731 |
| Atorvastatin | 0.15368 |
| All Treatments | -0.06310 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.06641 |
| Atorvastatin | -0.07964 |
| All Treatments | 0.02900 |
Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | -0.15721 |
| Atorvastatin | 0.16110 |
| All Treatments | -0.05794 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.16499 |
| Atorvastatin | 0.02609 |
| All Treatments | 0.15049 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.20021 |
| Atorvastatin | 0.12953 |
| All Treatments | 0.18870 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: Baseline and 26 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.18720 |
| Atorvastatin | 0.16167 |
| All Treatments | 0.18717 |
Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.) (NCT00296400)
Timeframe: 52 weeks
| Intervention | Correlation coefficient (Number) |
|---|
| Rosuvastatin | 0.21082 |
| Atorvastatin | -0.04379 |
| All Treatments | 0.14085 |
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 of the open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | 25.2 |
| ABT-335 + 40 mg Simvastatin | 25.1 |
| ABT-335 + 40 mg Atorvastatin | 19.4 |
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 of the open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -41.6 |
| ABT-335 + 40 mg Simvastatin | -30.2 |
| ABT-335 + 40 mg Atorvastatin | -38.1 |
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
(NCT00300430)
Timeframe: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy
| Intervention | percentage of participants (Number) |
|---|
| ABT-335 + 20 mg Rosuvastatin | 83 |
| ABT-335 + 40 mg Simvastatin | 86 |
| ABT-335 + 40 mg Atorvastatin | 85 |
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 of the open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -44.8 |
| ABT-335 + 40 mg Simvastatin | -35.5 |
| ABT-335 + 40 mg Atorvastatin | -42.9 |
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 of the open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -56.9 |
| ABT-335 + 40 mg Simvastatin | -37.7 |
| ABT-335 + 40 mg Atorvastatin | -52.2 |
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 of the open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -37.9 |
| ABT-335 + 40 mg Simvastatin | -27.5 |
| ABT-335 + 40 mg Atorvastatin | -35.0 |
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study
(NCT00300430)
Timeframe: Baseline to Week 52 in this open-label study
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -48.8 |
| ABT-335 + 40 mg Simvastatin | -36.6 |
| ABT-335 + 40 mg Atorvastatin | -44.3 |
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -55.8 |
| ABT-335 + 20 mg Rosuvastatin | -50.6 |
| ABT-335 | -31.9 |
| 10 mg Rosuvastatin | -41.0 |
| 20 mg Rosuvastatin | -42.1 |
| 40 mg Rosuvastatin | -49.1 |
Mean Percent Change in Triglycerides From Baseline to Final Visit
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -47.1 |
| ABT-335 + 20 mg Rosuvastatin | -42.9 |
| ABT-335 | -32.6 |
| 10 mg Rosuvastatin | -24.4 |
| 20 mg Rosuvastatin | -25.6 |
| 40 mg Rosuvastatin | -32.1 |
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -34.4 |
| ABT-335 + 20 mg Rosuvastatin | -35.7 |
| ABT-335 | -13.5 |
| 10 mg Rosuvastatin | -32.5 |
| 20 mg Rosuvastatin | -37.3 |
| 40 mg Rosuvastatin | -42.7 |
Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit
[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -44.7 |
| ABT-335 + 20 mg Rosuvastatin | -45.3 |
| ABT-335 | -18.5 |
| 10 mg Rosuvastatin | -39.8 |
| 20 mg Rosuvastatin | -45.8 |
| 40 mg Rosuvastatin | -51.5 |
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -37.2 |
| ABT-335 + 20 mg Rosuvastatin | -38.8 |
| ABT-335 | -6.5 |
| 10 mg Rosuvastatin | -38.0 |
| 20 mg Rosuvastatin | -45.0 |
| 40 mg Rosuvastatin | -50.6 |
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | -39.2 |
| ABT-335 + 20 mg Rosuvastatin | -39.2 |
| ABT-335 | -16.2 |
| 10 mg Rosuvastatin | -34.1 |
| 20 mg Rosuvastatin | -39.6 |
| 40 mg Rosuvastatin | -45.0 |
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100 (NCT00300482)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 10 mg Rosuvastatin | 20.3 |
| ABT-335 + 20 mg Rosuvastatin | 19.0 |
| ABT-335 | 15.0 |
| 10 mg Rosuvastatin | 8.5 |
| 20 mg Rosuvastatin | 10.3 |
| 40 mg Rosuvastatin | 9.3 |
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
(NCT00329160)
Timeframe: Baseline - 76Weeks
| Intervention | Percent change (Mean) |
|---|
| Rosuvastatin | 18.1 |
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges. (NCT00329160)
Timeframe: Baseline and 76 weeks
| Intervention | Percent Change (Mean) |
|---|
| Rosuvastatin | 14.1 |
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
(NCT00329160)
Timeframe: Baseline - 76Weeks
| Intervention | Percent change (Mean) |
|---|
| Rosuvastatin | 16.9 |
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Target Lesion indicates Coronary plaque composition of culprit lesions. (NCT00329160)
Timeframe: Baseline - 76Weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin | 12.074 |
Percent Change in Apolipoprotein B (ApoB)
Percent change in ApoB after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | -32.1 |
| Rosuva 10 | -37.8 |
| Rosuva 20 | -40.7 |
| Placebo | -1.5 |
Percent Change in LDL-C/HDL-C
Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 week of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | -40.4 |
| Rosuva 10 | -48.6 |
| Rosuva 20 | -53.6 |
| Placebo | -5.5 |
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100 (NCT00355615)
Timeframe: 12 weeks
| Intervention | percentage (Mean) |
|---|
| Rosuva 5 | -38.5 |
| Rosuva 10 | -44.4 |
| Rosuva 20 | -50.2 |
| Placebo | -0.5 |
Percent Change in Non-HDL-C at 12 Weeks
Percent change in non-HDL-C at 12 weeks (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | percent change (Mean) |
|---|
| Rosuva 5 | -36.3 |
| Rosuva 10 | -42.8 |
| Rosuva 20 | -47.7 |
| Placebo | -0.8 |
Percent Change in Non-HDL-C/HDL-C
Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | -37.9 |
| Rosuva 10 | -47.1 |
| Rosuva 20 | -51.2 |
| Placebo | -5.8 |
Percent Change in TC/HDL-C
Percent change in the ratio of TC/HDL-C after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | -32.1 |
| Rosuva 10 | -39.3 |
| Rosuva 20 | -43.2 |
| Placebo | -5.2 |
Percent Change in Total Cholesterol (TC)
Percent change from baseline in total cholesteral after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | percent change (Mean) |
|---|
| Rosuva 5 | -30.0 |
| Rosuva 10 | -34.1 |
| Rosuva 20 | -38.9 |
| Placebo | 0.2 |
Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment
Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group (NCT00355615)
Timeframe: 12 weeks
| Intervention | Percent of Participants (Number) |
|---|
| Rosuva 5 | 11.9 |
| Rosuva 10 | 40.9 |
| Rosuva 20 | 40.9 |
| Placebo | 0.0 |
Percent Change in Triglycerides (TG)
Percent change in tryglycerides (TG) after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | percent change (Mean) |
|---|
| Rosuva 5 | 2.6 |
| Rosuva 10 | -14.2 |
| Rosuva 20 | -7.9 |
| Placebo | 3.4 |
Percent Change in ApoB/ApoA-1
Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | -33.1 |
| Rosuva 10 | -40.0 |
| Rosuva 20 | -42.8 |
| Placebo | -3.4 |
Percent Change in Apolipoprotein A-1 (ApoA-1)
Percent change in ApoA-1 after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | mean percent change (Mean) |
|---|
| Rosuva 5 | 2.3 |
| Rosuva 10 | 4.3 |
| Rosuva 20 | 3.9 |
| Placebo | 3.6 |
Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)
Percent change from baseline in LDL-C after six week of treatment (NCT00355615)
Timeframe: 6 weeks
| Intervention | percentage (Mean) |
|---|
| Rosuva 5 | -40.3 |
| Rosuva 10 | -45.2 |
| Rosuva 20 | -50.0 |
| Placebo | -0.6 |
Percent Change in HDL-C
Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment (NCT00355615)
Timeframe: After 12 weeks of treatment
| Intervention | percent change (Mean) |
|---|
| Rosuva 5 | 4.5 |
| Rosuva 10 | 10.1 |
| Rosuva 20 | 8.9 |
| Placebo | 7.6 |
Percentage Change of Total Cholesterol (TC)
Calculate the percentage change of total cholesterol level (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | -34.10 |
| Atorvastatin | -28.80 |
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6
Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1. (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin | -44.40 |
| Atorvastatin | -36.50 |
Percentage Change of Apolipoprotein A1 (ApoA1)
Calculate the percentage change of Apolipoprotein A1 (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | 8.50 |
| Atorvastatin | 4.20 |
Percentage Change of Apolipoprotein B (ApoB)
Calculate the percentage change of apolipoprotein B (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | -40.50 |
| Atorvastatin | -34.60 |
Percentage Change of Glucose Level
Using laboratory test, mean change of glucose level was investigated. (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | Percentage change (Mean) |
|---|
| Rosuvastatin | -0.60 |
| Atorvastatin | 2.78 |
Percentage Change of High-Density Lipoprotein-C (HDL-C)
Calculate the percentage change of HDL-C level (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | 9.90 |
| Atorvastatin | 8.20 |
Percentage Change of Insulin Resistance Using HOMA-R
HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5 (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | 28.00 |
| Atorvastatin | 50.30 |
Percentage of Subjects Reaching Their LDL-C Target Goal
Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk). (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin | 88.20 |
| Atorvastatin | 75.40 |
Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal
Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal. (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin | 78.80 |
| Atorvastatin | 66.70 |
Percentage Change of Triglycerides (TG)
Calculate the percentage change of Triglycerides. (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | -17.20 |
| Atorvastatin | -15.10 |
Percentage Change of Insulin Resistance Using QUICKI
QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)]. (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | -1.27 |
| Atorvastatin | -1.03 |
Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)
Calculate the percentage reduction of LDL-C (NCT00395486)
Timeframe: Baseline and 6 weeks
| Intervention | percentage reduction (Mean) |
|---|
| Rosuvastatin | -45.50 |
| Atorvastatin | -37.90 |
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.
"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status." (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Rosuvastatin | 56.7 |
| Atorvastatin | 56.0 |
The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.
"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status." (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Rosuvastatin | 43 |
| Atorvastatin | 48 |
The Percentage Change From Baseline(week6) in TC
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in TC (Number) |
|---|
| Rosuvastatin | -23.03 |
| Atorvastatin | -26.88 |
The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in Non-HDL-C/HDL-C Ratio (Number) |
|---|
| Rosuvastatin | -31.05 |
| Atorvastatin | -35.48 |
The Percentage Change From Baseline (Week 6)in Non-HDL-C
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in Non-HDL-C (Number) |
|---|
| Rosuvastatin | -29.72 |
| Atorvastatin | -34.09 |
The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in LDL-C/HDL-C Ratio (Number) |
|---|
| Rosuvastatin | -34.75 |
| Atorvastatin | -38.45 |
The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in ApoB (Number) |
|---|
| Rosuvastatin | -25.96 |
| Atorvastatin | -28.67 |
The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in HDL-C (Number) |
|---|
| Rosuvastatin | 4.46 |
| Atorvastatin | 3.15 |
The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in ApoA1 (Number) |
|---|
| Rosuvastatin | -0.55 |
| Atorvastatin | 1.89 |
The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in ApoB/ApoA1 Ratio (Number) |
|---|
| Rosuvastatin | -22.89 |
| Atorvastatin | -28.75 |
Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)
Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in LDL-C (Number) |
|---|
| Rosuvastatin | 33.28 |
| Atorvastatin | 36.92 |
The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio
Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6 (NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percent Change in TC/HDL-C Ratio (Number) |
|---|
| Rosuvastatin | -24.99 |
| Atorvastatin | -28.42 |
The Percentage of Participants Reaching the Joint British Societies' Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L
(NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Rosuvastatin | 16 |
| Atorvastatin | 28 |
The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L
(NCT00427960)
Timeframe: 6 weeks (baseline) and 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Rosuvastatin | 13 |
| Atorvastatin | 12 |
The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L
(NCT00427960)
Timeframe: 6 weeks (Baseline) and 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Rosuvastatin | 50 |
| Atorvastatin | 64 |
Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end. (NCT00462748)
Timeframe: 6 Weeks
| Intervention | Percent (Number) |
|---|
| Ezetimibe/Simvastatin | 67.4 |
| Atorvostatin | 36.3 |
| Rosuvastatin | 17.4 |
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -28.7 |
| ABT-335 | -4.1 |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -37.4 |
| Rosuvastatin Calcium | -31.8 |
Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)
The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -28.1 |
| Rosuvastatin Calcium | -25.0 |
Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -40.3 |
| Rosuvastatin Calcium | -17.5 |
Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -41.3 |
| Rosuvastatin Calcium | -22.2 |
Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)
The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -37.4 |
| ABT-335 | -16.0 |
Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)
The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | -30.9 |
| Rosuvastatin Calcium | -26.4 |
Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. (NCT00463606)
Timeframe: Baseline to 12 Weeks
| Intervention | percent change (Mean) |
|---|
| ABT-335 and Rosuvastatin Calcium | 23.0 |
| Rosuvastatin Calcium | 12.4 |
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Reduction from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin 10 mg | 67.95 |
| Rosuvastatin 20 mg | 78.61 |
| Placebo | 22.31 |
HDL-C Increase
Increase from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin 10 mg | 3.49 |
| Rosuvastatin 20 mg | 2.49 |
| Placebo | 1.95 |
ApoA1 Levels
Change in the levels from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dl (Mean) |
|---|
| Rosuvastatin 10 mg | 4.66 |
| Rosuvastatin 20 mg | 6.79 |
| Placebo | 2.65 |
hsCRP Reduction
Reduction from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/L (Mean) |
|---|
| Rosuvastatin 10 mg | 0.19 |
| Rosuvastatin 20 mg | 0.11 |
| Placebo | -0.01 |
LDL-C Reduction
Reduction from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin 10 mg | 42.23 |
| Rosuvastatin 20 mg | 53.22 |
| Placebo | -2.66 |
Non-HDL-C Reduction
Reduction from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin 10 mg | 52.76 |
| Rosuvastatin 20 mg | 61.31 |
| Placebo | 1.06 |
Total Cholesterol Reduction
Reduction from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dL (Mean) |
|---|
| Rosuvastatin 10 mg | 49.73 |
| Rosuvastatin 20 mg | 63.32 |
| Placebo | -1.44 |
Adverse Events Reported
Number of participants with AEs and SAEs reported (NCT00473655)
Timeframe: 8 weeks
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 10 mg | 27 |
| Rosuvastatin 20 mg | 29 |
| Placebo | 20 |
ApoB Levels
Change in the levels from baseline to end of study (NCT00473655)
Timeframe: 8 weeks
| Intervention | mg/dl (Mean) |
|---|
| Rosuvastatin 10 mg | -27.05 |
| Rosuvastatin 20 mg | -36.81 |
| Placebo | 1.43 |
Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein
Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Median) |
|---|
| Ezetemibe + Simvastatin | -8.33 |
| Rosuvastatin | 0.00 |
Percent Change From Baseline in Triglycerides.
Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Median) |
|---|
| Ezetemibe + Simvastatin | -11.00 |
| Rosuvastatin | -5.26 |
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -27.66 |
| Rosuvastatin | -16.94 |
The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
"The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.~The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group." (NCT00479713)
Timeframe: after 6 weeks of treatment
| Intervention | Percent of participant population (Number) |
|---|
| LDL-C <100 | LDL-C <70 |
|---|
| Ezetemibe + Simvastatin | 72.46 | 25.25 |
,| Rosuvastatin | 56.23 | 11.11 |
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -27.41 |
| Rosuvastatin | -17.82 |
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | 2.12 |
| Rosuvastatin | 3.03 |
Percent Change From Baseline in Apolipoprotein B
Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -17.87 |
| Rosuvastatin | -9.77 |
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)
Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -23.42 |
| Rosuvastatin | -14.01 |
Percent Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -17.53 |
| Rosuvastatin | -10.33 |
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100. (NCT00479713)
Timeframe: Baseline and 6 weeks
| Intervention | percent change from baseline (Least Squares Mean) |
|---|
| Ezetemibe + Simvastatin | -17.76 |
| Rosuvastatin | -11.51 |
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy. (NCT00491530)
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -33.7 |
| ABT-335 + 40 mg Simvastatin | -18.7 |
| ABT-335 + 40 mg Atorvastatin | -26.6 |
Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study
[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy. (NCT00491530)
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -20.1 |
| ABT-335 + 40 mg Simvastatin | -17.9 |
| ABT-335 + 40 mg Atorvastatin | -20.4 |
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy. (NCT00491530)
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -26.9 |
| ABT-335 + 40 mg Simvastatin | -23.8 |
| ABT-335 + 40 mg Atorvastatin | -25.1 |
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy. (NCT00491530)
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | 13.7 |
| ABT-335 + 40 mg Simvastatin | 11.2 |
| ABT-335 + 40 mg Atorvastatin | 5.2 |
Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy. (NCT00491530)
Timeframe: Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)
| Intervention | percent change (Mean) |
|---|
| ABT-335 + 20 mg Rosuvastatin | -19.2 |
| ABT-335 + 40 mg Simvastatin | -20.2 |
| ABT-335 + 40 mg Atorvastatin | -20.5 |
Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study
All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening. (NCT00491530)
Timeframe: Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.
| Intervention | percentage of participants (Number) |
|---|
| ABT-335 + 20 mg Rosuvastatin | 94.8 |
| ABT-335 + 40 mg Simvastatin | 90.0 |
| ABT-335 + 40 mg Atorvastatin | 97.7 |
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -47.3900 |
| R20 to R20 + E10 | -50.2400 |
| S40 to S40 + E10 | -42.5400 |
| S80 to S80 + E10 | -44.7600 |
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | 3.8100 |
| R20 to R20 + E10 | 2.6800 |
| S40 to S40 + E10 | 1.4900 |
| S80 to S80 + E10 | 2.1300 |
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -46.1100 |
| R20 to R20 + E10 | -49.5000 |
| S40 to S40 + E10 | -41.9500 |
| S80 to S80 + E10 | -44.1700 |
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | 6.4100 |
| R20 to R20 + E10 | 7.4600 |
| S40 to S40 + E10 | 3.9200 |
| S80 to S80 + E10 | 4.3400 |
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | 107.1200 |
| R20 to R20 + E10 | -9.5300 |
| S40 to S40 + E10 | 15.0300 |
| S80 to S80 + E10 | 0.4200 |
Percent Change in LDL-C After 6 Weeks Monotherapy
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -46.4900 |
| R20 to R20 + E10 | -53.5900 |
| S40 to S40 + E10 | -40.8600 |
| S80 to S80 + E10 | -46.3500 |
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -61.4700 |
| R20 to R20 + E10 | -65.2500 |
| S40 to S40 + E10 | -57.1300 |
| S80 to S80 + E10 | -58.6600 |
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -56.4200 |
| R20 to R20 + E10 | -60.8900 |
| S40 to S40 + E10 | -51.1100 |
| S80 to S80 + E10 | -53.5100 |
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -54.6500 |
| R20 to R20 + E10 | -58.9100 |
| S40 to S40 + E10 | -49.9300 |
| S80 to S80 + E10 | -52.3700 |
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -45.5200 |
| R20 to R20 + E10 | -49.4600 |
| S40 to S40 + E10 | -41.2700 |
| S80 to S80 + E10 | -43.4500 |
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -43.0000 |
| R20 to R20 + E10 | -46.6300 |
| S40 to S40 + E10 | -39.5600 |
| S80 to S80 + E10 | -41.7100 |
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -28.8500 |
| R20 to R20 + E10 | -35.0000 |
| S40 to S40 + E10 | -22.9500 |
| S80 to S80 + E10 | -25.8200 |
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100 (NCT00525824)
Timeframe: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
| Intervention | Percentage (Mean) |
|---|
| R10 to R10 + E10 | -59.7200 |
| R20 to R20 + E10 | -63.4800 |
| S40 to S40 + E10 | -55.2200 |
| S80 to S80 + E10 | -57.4200 |
Non-HDL-C/HDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | Ratio (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 1.88 |
| Atorvastatin 80 mg | 2.08 |
Numbers of Patients Showing Regression in PAV
Regression defined as a change from baseline in PAV < 0 (NCT00620542)
Timeframe: End of study (Week 104)
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 40 mg | 356 |
| Atorvastatin 80 mg | 328 |
Numbers of Patients Showing Regression in TAV
Regression defined as a change from baseline in TAV < 0 (NCT00620542)
Timeframe: End of study (Week 104)
| Intervention | Participants (Number) |
|---|
| Rosuvastatin 40 mg | 371 |
| Atorvastatin 80 mg | 336 |
Total Cholesterol Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 139.38 |
| Atorvastatin 80 mg | 144.05 |
Total Cholesterol/HDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | Ratio (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 2.88 |
| Atorvastatin 80 mg | 3.08 |
Triglycerides Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 132.50 |
| Atorvastatin 80 mg | 126.58 |
VLDL-C During the 104 Week Treatment Period
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 26.05 |
| Atorvastatin 80 mg | 25.03 |
LDL-C/HDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | Ratio (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 1.30 |
| Atorvastatin 80 mg | 1.50 |
LDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 62.64 |
| Atorvastatin 80 mg | 70.18 |
HDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 50.43 |
| Atorvastatin 80 mg | 48.64 |
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population. (NCT00620542)
Timeframe: End of study (Week 104)
| Intervention | mm^3 (Median) |
|---|
| Rosuvastatin 40 mg | -6.39 |
| Atorvastatin 80 mg | -4.42 |
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
"Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:~[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD." (NCT00620542)
Timeframe: End of study (Week 104)
| Intervention | Percent change (Median) |
|---|
| Rosuvastatin 40 mg | -1.22 |
| Atorvastatin 80 mg | -0.99 |
Non-HDL-C Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 88.95 |
| Atorvastatin 80 mg | 95.41 |
Apolipoprotein B Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 72.55 |
| Atorvastatin 80 mg | 75.12 |
Apolipoprotein A-1 Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 146.81 |
| Atorvastatin 80 mg | 137.68 |
Apoliprotein B/Apolipoprotein A-1 Blood Level
Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. (NCT00620542)
Timeframe: 104 weeks
| Intervention | Ratio (Least Squares Mean) |
|---|
| Rosuvastatin 40 mg | 0.51 |
| Atorvastatin 80 mg | 0.56 |
Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients
To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0-1) risk factor (NCT00631189)
Timeframe: from baseline and after 8 weeks of treatment
| Intervention | Participants (Number) |
|---|
| Atorvastatin | 42 |
| Pravastatin | 22 |
| Rosuvastatin | 38 |
Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment
Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: After 8 weeks of treatment
| Intervention | percentage of HDL-C increase (Mean) |
|---|
| Atorvastatin | 4.4 |
| Pravastatin | 7.9 |
| Rosuvastatin | 11.3 |
Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment
To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: from baseline and after 8 weeks of treatment
| Intervention | percentage of total cholesterol decrease (Mean) |
|---|
| Atorvastatin | -28.6 |
| Pravastatin | -20.4 |
| Rosuvastatin | -25.2 |
Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment
To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: baseline and after 8 weeks of treatment
| Intervention | percent. Apolipoprotein B/A1 decrease (Mean) |
|---|
| Atorvastatin | -30.9 |
| Pravastatin | -26 |
| Rosuvastatin | -31.9 |
Compare the Percentage of Variation of C-reactive Protein (CRP)
To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: baseline and after 8 weeks of treatment
| Intervention | percent of variation of C-reactive prot. (Mean) |
|---|
| Atorvastatin | 37.3 |
| Pravastatin | 33.1 |
| Rosuvastatin | 15.2 |
Compare the Percentage of Variation of Phospholipase A2 (PLA2)
To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: from baseline and after 8 weeks of treatment
| Intervention | percent of variation of phospholipase A2 (Mean) |
|---|
| Atorvastatin | 5.6 |
| Pravastatin | 13 |
| Rosuvastatin | 2.9 |
Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks
To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: Baseline and after 8 weeks of treatment
| Intervention | percentage of triglycerides decrease (Mean) |
|---|
| Atorvastatin | -19.2 |
| Pravastatin | -6.1 |
| Rosuvastatin | -8.7 |
To Evaluate Clinical and Laboratory Safety
Serious Adverse Event and Adverse Event reported throughout the study (NCT00631189)
Timeframe: duration of study
| Intervention | Adverse Events (Number) |
|---|
| Initial Phase | 8 |
| Atorvastatin | 9 |
| Pravastatin | 8 |
| Rosuvastatin | 5 |
Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks
To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data (NCT00631189)
Timeframe: Change from baseline and after 8 weeks of treatment
| Intervention | percentage of LDL-C decrease (Mean) |
|---|
| Atorvastatin | -39.4 |
| Pravastatin | -30.3 |
| Rosuvastatin | -37.6 |
Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL). (NCT00680017)
Timeframe: Baseline to 8 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| ABT-335 Plus Rosuvastatin | 16.9 |
| Rosuvastatin | 7.8 |
Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -41.79 |
| Rosuvastatin 10mg | -56.63 |
| Atorvastatin 10mg | -48.33 |
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -38.60 |
| Rosuvastatin 10mg | -46.08 |
| Atorvastatin 10mg | -38.50 |
Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -32.95 |
| Rosuvastatin 10mg | -38.04 |
| Atorvastatin 10mg | -31.92 |
Percentage Change From Baseline in Triglycerides (TG) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | Percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -20.09 |
| Rosuvastatin 10mg | -22.05 |
| Atorvastatin 10mg | -20.67 |
Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6
"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)" (NCT00683618)
Timeframe: week 6
| Intervention | percentage of patients (Number) |
|---|
| Rosuvastatin 5mg | 61.0 |
| Rosuvastatin 10mg | 79.1 |
| Atorvastatin 10mg | 58.3 |
Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration
"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)" (NCT00683618)
Timeframe: from week 6 to week 12
| Intervention | percentage of patients (Number) |
|---|
| Rosuvastatin 5mg | 41.2 |
| Rosuvastatin 10mg | 47.6 |
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -29.62 |
| Rosuvastatin 10mg | -33.14 |
| Atorvastatin 10mg | -28.06 |
6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6
"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)" (NCT00683618)
Timeframe: week 6
| Intervention | percentage of patients (Number) |
|---|
| Rosuvastatin 5mg | 66.9 |
| Rosuvastatin 10mg | 78.4 |
| Atorvastatin 10mg | 60.4 |
Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | 3.67 |
| Rosuvastatin 10mg | 4.25 |
| Atorvastatin 10mg | 1.79 |
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -36.55 |
| Rosuvastatin 10mg | -41.21 |
| Atorvastatin 10mg | -34.67 |
Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -37.62 |
| Rosuvastatin 10mg | -41.87 |
| Atorvastatin 10mg | -35.15 |
Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | 5.63 |
| Rosuvastatin 10mg | 6.82 |
| Atorvastatin 10mg | 3.64 |
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | Percent change (Least Squares Mean) |
|---|
| Rosuvastatin 10mg | -46.28 |
| Atorvastatin 10mg | -38.67 |
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -41.70 |
| Atorvastatin 10mg | -38.67 |
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. (NCT00683618)
Timeframe: baseline, 6 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 5mg | -44.07 |
| Rosuvastatin 10mg | -50.27 |
| Atorvastatin 10mg | -41.04 |
Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy
The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100 (NCT00747149)
Timeframe: 12 Weeks
| Intervention | Percentage (Mean) |
|---|
| Rosuvastatin 10 mg (Initial) | 87 |
| Rosuvastatin 20 mg (Initial) | 87 |
| Rosuvastatin 20 mg (Titrated) | 76 |
| Rosuvastatin 40 mg (Titrated) | 63 |
Number of Participants in Each Stratum Who Reached Their Target LDL-C Level
Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks. (NCT00783263)
Timeframe: 6 weeks of treatment
| Intervention | participants (Number) |
|---|
| Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I) | 54 |
| Rosuvastatin 10 mg (Stratum I) | 30 |
| Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II) | 76 |
| Rosuvastatin 20 mg (Stratum II) | 37 |
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. (NCT00783263)
Timeframe: Baseline to 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I) | -18.57 |
| Rosuvastatin 10 mg (Stratum I) | -4.96 |
| Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II) | -24.00 |
| Rosuvastatin 20 mg (Stratum II) | -6.07 |
Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels
Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment. (NCT00783263)
Timeframe: Baseline to 6 weeks
| Intervention | percentage change (Mean) |
|---|
| Total Cholesterol (TC) | Triglycerides | High-Density Lipoprotein Cholesterol | Non High-Density Liproprotein Cholesterol | LDL Cholesterol/HDL Cholesterol | Total Cholesterol/HDL Cholesterol | Non-HDL Cholestrol/HDL Cholesterol | Apolipoprotein B (Apo B) | Apolipoprotein A-I (Apo A-I) | Apolipoprotein B/Apo A-I | hs-C-Reactive Protein |
|---|
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | -13.00 | -5.96 | -0.67 | -17.59 | -19.48 | -10.57 | -14.51 | -14.31 | -1.44 | -11.98 | -13.98 |
,| Rosuvastatin 10 or 20 mg | -3.76 | -3.60 | 2.18 | -5.29 | -6.18 | -4.40 | -5.31 | -4.25 | 1.06 | -4.11 | -12.82 |
Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment
The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. (NCT00783263)
Timeframe: Baseline to 6 weeks
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | -21.57 |
| Rosuvastatin (10 or 20 mg) | -5.58 |
Number of Participants Who Reached Their Target LDL-C Level
Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment. (NCT00783263)
Timeframe: 6 weeks of treatment
| Intervention | participants (Number) |
|---|
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | 130 |
| Rosuvastatin (10 or 20 mg) | 67 |
Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl
Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg). (NCT00783263)
Timeframe: 6 weeks of treatment
| Intervention | participants (Number) |
|---|
| Rosuvastatin 5 mg + Ezetimibe 10 mg | 31 |
| Rosuvastatin 10 mg | 12 |
| Rosuvastatin 10 mg + Ezetimibe 10 mg | 65 |
| Rosuvastatin 20 mg | 26 |
Number of Participants Who Reached the LDL-C Level of <70 mg/dl
Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks. (NCT00783263)
Timeframe: 6 weeks of treatment
| Intervention | participants (Number) |
|---|
| Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg | 96 |
| Rosuvastatin 10 or 20 mg | 38 |
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 6.7 |
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 43.4 |
Basal Tumor Necrosis Factor (TNF) Level
TNF levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 10.8 |
Basal Triglyceride Level
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 195.1 |
Basal Total Cholesterol Level
Baseline (NCT00815659)
Timeframe: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 236.5 |
Basal Small HDL Subfraction Level
Small HDL subfraction levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 6.2 |
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | Participants (Number) |
|---|
| Crestor | 48 |
Basal LDL-cholesterol Level
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 165.5 |
Basal LDL-7 Level
LDL-7 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 0.5 |
Basal LDL-5 Level
LDL-5 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 2.7 |
Basal LDL-4 Level
LDL-4 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 7.9 |
Basal LDL-3 Level
LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 15.5 |
Basal Interleukin 8 (IL-8) Level
IL-8 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 10.7 |
Basal Interleukin 6 (IL-6) Level
IL-6 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 2.6 |
Basal Interleukin 10 (IL-10) Level
IL-10 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 4.2 |
Basal Interleukin 1 (IL-1) Level
IL-1 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 4.1 |
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
hs-CRP levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 8.2 |
Basal HDL-cholesterol Level
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 39.5 |
LDL-4 Level After 3 Months of Rosuvastatin Treatment
LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 3.5 |
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 12.9 |
Triglyceride Level After 3 Months of Rosuvastatin Treatment
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 153.1 |
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 166.2 |
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 6.6 |
Number of Patients With Adverse Events
Number of patients with any adverse events in 3 months of rosuvastatin treatment (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | Participants (Number) |
|---|
| Crestor | 24 |
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | Participants (Number) |
|---|
| Crestor | 51 |
Basal Large HDL Subfraction Level
Large HDL subfraction levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 15.0 |
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | Participants (Number) |
|---|
| Crestor | 39 |
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/dL (Mean) |
|---|
| Crestor | 98.3 |
LDL-7 Level After 3 Months of Rosuvastatin Treatment
LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 0.8 |
LDL-6 Level After 3 Months of Rosuvastatin Treatment
LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 0.3 |
LDL-5 Level After 3 Months of Rosuvastatin Treatment
LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 1.3 |
LDL-3 Level After 3 Months of Rosuvastatin Treatment
LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 8.8 |
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 17.6 |
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 12.7 |
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 2.8 |
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 4.8 |
Basal LDL-6 Level
LDL-6 levels before (Visit 2-enrollment) (NCT00815659)
Timeframe: Baseline
| Intervention | mg/mL (Mean) |
|---|
| Crestor | 0.5 |
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) (NCT00815659)
Timeframe: 3 months (from enrollment to last visit)
| Intervention | pg/mL (Mean) |
|---|
| Crestor | 4.1 |
Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8
Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group). (NCT00850460)
Timeframe: Week 0 to Week 8
| Intervention | units on a scale (Mean) |
|---|
| Week 0 Mean Score | Week 8 Mean Score |
|---|
| Placebo | 65 | 67 |
,| Statins | 76 | 50 |
Percent Change From Baseline in Triglycerides
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -5.51 |
| Doubling Statin Dose | -2.63 |
| Rosuvastatin | -3.35 |
Percent Change From Baseline in Total Cholesterol (TC)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent Change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -13.21 |
| Doubling Statin Dose | -4.88 |
| Rosuvastatin | -10.58 |
Percent Change From Baseline in TC/HDL-C Ratio
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -12.52 |
| Doubling Statin Dose | -4.36 |
| Rosuvastatin | -10.70 |
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -4.42 |
| Doubling Statin Dose | -1.64 |
| Rosuvastatin | -9.11 |
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -16.77 |
| Doubling Statin Dose | -5.32 |
| Rosuvastatin | -14.64 |
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -23.13 |
| Doubling Statin Dose | -8.37 |
Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -23.13 |
| Rosuvastatin | -19.32 |
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | 1.47 |
| Doubling Statin Dose | 1.00 |
| Rosuvastatin | 1.99 |
Percent Change From Baseline in Apolipoprotein B (Apo B)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -14.98 |
| Doubling Statin Dose | -6.97 |
| Rosuvastatin | -12.03 |
Percent Change From Baseline in Apo B/Apo A-I Ratio
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -13.67 |
| Doubling Statin Dose | -4.75 |
| Rosuvastatin | -11.14 |
Percent Change From Baseline Apolipoprotein A-I (Apo A-I)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | 0.64 |
| Doubling Statin Dose | -0.93 |
| Rosuvastatin | 0.86 |
Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
(NCT00862251)
Timeframe: Week 6
| Intervention | participants (Number) |
|---|
| Ezetimibe/Simvastatin | 171 |
| Doubling Statin Dose | 43 |
| Rosuvastatin | 134 |
In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -21.59 |
| Doubling Simvastatin Dose | -7.98 |
In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
(NCT00862251)
Timeframe: Week 6
| Intervention | participants (Number) |
|---|
| Ezetimibe/Simvastatin | 84 |
| Doubling Simvastatin Dose | 19 |
In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -24.58 |
| Doubling Atorvastatin Dose | -8.85 |
In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)
(NCT00862251)
Timeframe: Week 6
| Intervention | participants (Number) |
|---|
| Ezetimibe/Simvastatin | 87 |
| Doubling Atorvastatin Dose | 24 |
Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -18.39 |
| Doubling Statin Dose | -6.77 |
| Rosuvastatin | -15.14 |
Percent Change From Baseline in LDL-C/HDL-C Ratio
(NCT00862251)
Timeframe: Baseline and Week 6
| Intervention | Percent change (Least Squares Mean) |
|---|
| Ezetimibe/Simvastatin | -21.55 |
| Doubling Statin Dose | -7.39 |
| Rosuvastatin | -18.99 |
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation. (NCT00871351)
Timeframe: End of Week 4 to Week 16 or discontinuation
| Intervention | Percent change (Mean) |
|---|
| Total Cholesterol | Triglycerides | High-Density Lipoprotein Cholesterol (HDL-C) | Non-HDL-C | High Sensitivity C-Reactive Protein (Hs-CRP) |
|---|
| Atorvastatin | -10.3 | 0.2 | 0.5 | -13.7 | 9.9 |
,| Ezetimibe + Atorvastatin | -18.0 | -0.8 | 4.5 | -25.0 | 49.0 |
,| Rosuvastatin | 1.9 | 14.7 | 2.5 | 2.0 | 25.7 |
Percent Change in Total Lipids and Hs-CRP
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation). (NCT00871351)
Timeframe: End of washout to Week 16 or discontinuation
| Intervention | Percent change (Mean) |
|---|
| Total Cholesterol | Triglycerides | High-Density Lipoprotein Cholesterol (HDL-C) | Non-HDL-C | High Sensitivity C-reactive Protein (Hs-CRP) |
|---|
| Atorvastatin | -32.8 | -18.8 | 7.4 | -41.4 | -2.9 |
,| Ezetimibe + Atorvastatin | -39.9 | -25.3 | 10.3 | -50.1 | 73.0 |
,| Rosuvastatin | -24.4 | -12.0 | 9.9 | -31.3 | -13.6 |
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
"LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).~Target values:~For participants with history of coronary artery disease: <100 mg/dL;~for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;~for participants with 1-2 CV risk factors: <140 mg/dL;~for participants with no CV risk factors: <160 mg/dL." (NCT00871351)
Timeframe: Week 16 or discontinuation
| Intervention | Participants (Number) |
|---|
| Ezetimibe + Atorvastatin | 37 |
| Atorvastatin | 19 |
| Rosuvastatin | 1 |
Percent Change in LDL-C
LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation). (NCT00871351)
Timeframe: End of washout period to Week 16 or discontinuation
| Intervention | Percent change (Mean) |
|---|
| Ezetimibe + Atorvastatin | -49.6 |
| Atorvastatin | -41.1 |
| Rosuvastatin | -30.5 |
Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation). (NCT00871351)
Timeframe: End of Week 4 to Week 16 or discontinuation
| Intervention | Percent change (Mean) |
|---|
| Ezetimibe + Atorvastatin | -25.8 |
| Atorvastatin | -15.1 |
| Rosuvastatin | 0.8 |
Cmax of Rosuvastatin
(NCT00885495)
Timeframe: 7 days
| Intervention | ng/mL (Geometric Mean) |
|---|
| Rosuvastatin | 6.70 |
| Rosuvastatin-Darunavir-Ritonavir | 16.32 |
AUC of Rosuvastatin
(NCT00885495)
Timeframe: 7 days
| Intervention | ng*hr/mL (Geometric Mean) |
|---|
| Rosuvastatin | 108.96 |
| Rosuvastatin-Darunavir-Ritonavir | 161.24 |
To Investigate the Effect of Rosuvastatin on the Steady State Pharmacokinetics of Darunavir/Ritonavir.
Geometric mean of the Concentration minimum of darunavir and ritonavir in the presence and absence of rosuvastatin. (NCT00885495)
Timeframe: 45 days
| Intervention | ng/mL (Geometric Mean) |
|---|
| Darunavir Cmin with Rosuvastatin | Darunavir Cmin absent Rosuvastatin | Ritonavir Cmin absent Rousuvastatin | Ritonavir Cmin with Rousuvastatin present |
|---|
| Darunavir/Ritonavir+Rosuvastatin | 2744 | 3235 | 194 | 148 |
To Compare the Change in Low-density Lipoprotein (LDL) Cholesterol With Rosuvastatin Therapy Alone, Darunavir/Ritonavir Therapy Alone and With the Co-administration of Rosuvastatin and Darunavir/Ritonavir.
LDL values (NCT00885495)
Timeframe: 45 days
| Intervention | mg/dL (Median) |
|---|
| Rosuvastatin Alone | 85 |
| Darunavir/Ritonavir | 115 |
| Rosuvastatin+Darunavir/Ritonavir | 80 |
The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.
(NCT00908011)
Timeframe: 3 months from baseline
| Intervention | mmol/L (Mean) |
|---|
| Ezetimibe | 0.88 |
| Standard Care | 0.89 |
Relative Change in High-sensitivity C-reactive Protein
(NCT00929734)
Timeframe: Baseline to 3 months
| Intervention | percent change (Median) |
|---|
| Rosuvastatin | -20.0 |
| Placebo | 11.0 |
Relative Change in Reactive Hyperemia Index (RHI)
Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment. (NCT00929734)
Timeframe: Baseline to 3 months
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin | 6.65 |
| Placebo | -1.27 |
Relative Change in Interleukin 6
(NCT00929734)
Timeframe: Baseline to 3 months
| Intervention | percent change (Median) |
|---|
| Rosuvastatin | 8 |
| Placebo | 30 |
Relative Change in FEV1
(NCT00929734)
Timeframe: Baseline to 3 months
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin | 2.6 |
| Placebo | -1.1 |
Organ Failure Free Days at Day 14
The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function. (NCT00979121)
Timeframe: 14 days after randomization
| Intervention | days (Mean) |
|---|
| Cardiovascular | Coagulation | Hepatic | Renal |
|---|
| Placebo | 8.7 | 11.1 | 11.8 | 11.0 |
,| Rosuvastatin | 8.5 | 10.7 | 10.8 | 10.1 |
Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14
CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis. (NCT00979121)
Timeframe: 6 and 14 days after randomization
| Intervention | mg/dL (Mean) |
|---|
| Day 6 | Day 14 |
|---|
| Placebo | -15.1 | -14.8 |
,| Rosuvastatin | -12.9 | -19.8 |
Ventilator Free Days at Study Day 28
Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given. (NCT00979121)
Timeframe: time of initiating unassisted breathing to day 28 after study randomization
| Intervention | days (Mean) |
|---|
| Rosuvastatin | 15.1 |
| Placebo | 15.1 |
ICU Free Days to Day 28
(NCT00979121)
Timeframe: 28 days after randomization
| Intervention | days (Mean) |
|---|
| Rosuvastatin | 14.3 |
| Placebo | 14.4 |
Hospital Mortality to Day 60.
The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60. (NCT00979121)
Timeframe: 60 days after randomization
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin | 28.5 |
| Placebo | 24.9 |
Other Secondary Out-comes
Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured. (NCT00979121)
Timeframe: 28 days after randomization
| Intervention | percentage of participants (Number) |
|---|
| Arrhythmias | Bowel Ischemia | Myocardial Infarction | Ischemic Stroke | Thromboembolism |
|---|
| Placebo | 8.4 | 1.9 | 0.6 | 0.3 | 6.9 |
,| Rosuvastatin | 9.0 | 1.4 | 0.5 | 0.3 | 6.3 |
Overall Survival (OS)
Number of patients with the OS event (death from any cause) (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | participants with OS event (Number) |
|---|
| Group 1: Placebo | 1 |
| Group 2: Rosuvastatin | 4 |
Second Non-colorectal Primary Cancer-free Interval
Number of patients with the first occurrence of non-colorectal primary cancer (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | participants non-colorectal primary cx (Number) |
|---|
| Group 1: Placebo | 4 |
| Group 2: Rosuvastatin | 7 |
Size of Colorectal Adenomas, Including Advanced Adenomas
The histologic size (diameter of adenoma into the wall of the colon; as per AJCC staging) of the largest adenoma among patients who have at least one adenoma detected. If histologic size was not available, the endoscopic size was provided. (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | centimeters (Median) |
|---|
| Group 1: Placebo | 0.4 |
| Group 2: Rosuvastatin | 0.4 |
Toxicity Assessed by Adverse Events
Percentage of patients with at least one grade 2 or higher adverse event reported. (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | percentage of patients (Number) |
|---|
| Group 1: Placebo | 41.4 |
| Group 2: Rosuvastatin | 45.4 |
Recurrence-free Interval (RFI)
Number of patients with the RFI event (First recurrence of colon cancer) (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | participants with RFI event (Number) |
|---|
| Group 1: Placebo | 12 |
| Group 2: Rosuvastatin | 14 |
Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist
Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status. (NCT01011478)
Timeframe: 12-month time point
| Intervention | score on a scale (Median) |
|---|
| Group 1: Placebo | 8.0 |
| Group 2: Rosuvastatin | 8.0 |
Disease-free Survival
Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause) (NCT01011478)
Timeframe: Up to 4.8 years
| Intervention | participants with DFS event (Number) |
|---|
| Group 1: Placebo | 17 |
| Group 2: Rosuvastatin | 21 |
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
(NCT01068626)
Timeframe: 6 months
| Intervention | cm2 (Mean) |
|---|
| Rosuvastatin | -1.5 |
| Placebo for Rosuvastatin | 2.8 |
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
(NCT01068626)
Timeframe: 6 months
| Intervention | ratio (Mean) |
|---|
| Rosuvastatin | -0.02 |
| Placebo for Rosuvastatin | 0.01 |
Change in Subcutaneous Adipose Tissue Area
(NCT01068626)
Timeframe: 6 months
| Intervention | cm2 (Mean) |
|---|
| Rosuvastatin | 10 |
| Placebo for Rosuvastatin | 1 |
Change in Hepatic Fat Infiltration Measured by CT.
(NCT01068626)
Timeframe: 6 months
| Intervention | Hounsfield units (Mean) |
|---|
| Rosuvastatin | 0 |
| Placebo for Rosuvastatin | -2 |
Change in Body Weight
(NCT01068626)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|
| Rosuvastatin | 0.2 |
| Placebo for Rosuvastatin | 0.5 |
Change in LDL
(NCT01068626)
Timeframe: 6 months
| Intervention | mmol/L (Mean) |
|---|
| Rosuvastatin | -1.4 |
| Placebo for Rosuvastatin | -0.1 |
Total Duration of Exposure
Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: 2-year study period
| Intervention | Days (Mean) |
|---|
| Rosuvastatin | 703.5 |
Adverse Events
Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: 2-year study period
| Intervention | Participant (Number) |
|---|
| Any AE | AE Leading to Death | AE Leading to Discontinuation | Serious AE | Treatment Related AE | Treatment Related AE Leading to Death | Treatment Related AE Leading to Discontinuation | Treatment Related Serious AE |
|---|
| Rosuvastatin | 172 | 0 | 3 | 9 | 29 | 0 | 3 | 0 |
Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: At Month 3, Month 12 and Month 24
| Intervention | Percent change (Mean) |
|---|
| HDL-C %Change from Baseline at Month 3 | HDL-C %Change from Baseline at Month 12 | HDL-C %Change from Baseline at Month 24 | TC %Change from Baseline at Month 3 | TC %Change from Baseline at Month 12 | TC %Change from Baseline at Month 24 | Triglycerides %Change from Baseline at Month 3 | Triglycerides %Change from Baseline at Month 12 | Triglycerides %Change from Baseline at Month 24 | non-HDL C %Change from Baseline at Month 3 | non-HDL C %Change from Baseline at Month 12 | non-HDL C %Change from Baseline at Month 24 | LDL-C/HDL-C %Change from Baseline at Month 3 | LDL-C/HDL-C %Change from Baseline at Month 12 | LDL-C/HDL-C %Change from Baseline at Month 24 | TC/HDL-C %Change from Baseline at Month 3 | TC/HDL-C %Change from Baseline at Month 12 | TC/HDL-C %Change from Baseline at Month 24 | Trig/HDL-C %Change from Baseline at Month 3 | Trig/HDL-C %Change from Baseline at Month 12 | Trig/HDL-C %Change from Baseline at Month 24 | non-HDL-C/HDL-C %Change from Baseline at Month 3 | non-HDL-C/HDL-C %Change from Baseline at Month 12 | non-HDL-C/HDL-C %Change from Baseline at Month 24 | ApoA-I %Change from Baseline at Month 3 | ApoA-I %Change from Baseline at Month 12 | ApoA-I %Change from Baseline at Month 24 | ApoB %Change from Baseline at Month 3 | ApoB %Change from Baseline at Month 12 | ApoB %Change from Baseline at Month 24 | ApoB/ApoA-I %Change from Baseline at Month 3 | ApoB/ApoA-I %Change from Baseline at Month 12 | ApoB/ApoA-I %Change from Baseline at Month 24 | hsCRP %Change from Baseline at Month 3 | hsCRP %Change from Baseline at Month 12 | hsCRP %Change from Baseline at Month 24 |
|---|
| Rosuvastatin | 5.67 | 6.35 | 11.73 | -29.60 | -33.91 | -32.03 | -7.95 | -7.85 | -0.12 | -36.35 | -41.66 | -40.40 | -39.66 | -45.63 | -46.95 | -31.77 | -36.54 | -37.39 | -9.05 | -10.50 | -7.12 | -37.98 | -43.71 | -44.74 | 4.77 | 1.41 | 2.34 | -29.29 | -35.65 | -35.72 | -31.30 | -35.66 | -35.94 | 512.57 | 42.96 | 98.36 |
Sexual Maturation by Tanner Staging at Baseline
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. (NCT01078675)
Timeframe: At Baseline
| Intervention | Participants (Number) |
|---|
| Tanner Stage I at Baseline | Tanner Stage II at Baseline | Tanner Stage III at Baseline | Tanner Stage IV at Baseline | Tanner Stage V at Baseline | Not Recorded at Baseline |
|---|
| Rosuvastatin | 81 | 32 | 18 | 44 | 21 | 1 |
Sexual Maturation by Tanner Staging at Month 24
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. (NCT01078675)
Timeframe: At Baseline
| Intervention | Participants (Number) |
|---|
| Tanner Stage I at Month 24 | Tanner Stage II at Month 24 | Tanner Stage III at Month 24 | Tanner Stage IV at Month 24 | Tanner Stage V at Month 24 | Not Recorded at Month 24 |
|---|
| Rosuvastatin | 43 | 33 | 23 | 32 | 64 | 2 |
Percent Change From Baseline in Height
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: At Month 12 and Month 24
| Intervention | Percent change (Mean) |
|---|
| %Change from Baseline at Month 12 | %Change from Baseline at Month 24 |
|---|
| Rosuvastatin | 3.20 | 5.91 |
Sexual Maturation by Tanner Staging at Month 12
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. (NCT01078675)
Timeframe: At Baseline
| Intervention | Participants (Number) |
|---|
| Tanner Stage I at Month 12 | Tanner Stage II at Month 12 | Tanner Stage III at Month 12 | Tanner Stage IV at Month 12 | Tanner Stage V at Month 12 | Not Recorded at Month 12 |
|---|
| Rosuvastatin | 61 | 31 | 21 | 32 | 42 | 10 |
Overal Treatment Adherence
Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: 2-year study period
| Intervention | Percent of doses (Mean) |
|---|
| Rosuvastatin | 89.6 |
Percent Change From Baseline in LDL-C
Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. (NCT01078675)
Timeframe: At Month 3, Month 12 and Month 24
| Intervention | Percentage change (Mean) |
|---|
| LDL-C %Change from Baseline at month 3 | LDL-C %Change from Baseline at month 12 | LDL-C %Change from Baseline at month 24 |
|---|
| Rosuvastatin | -37.86 | -43.67 | -42.88 |
Single Dose PK - AUC(0-24)
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing (NCT01078675)
Timeframe: Serial blood samples over 24 hours
| Intervention | ng*hr/mL (Mean) |
|---|
| Rosuvastatin | 27.675 |
Single Dose PK - Cmax
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing (NCT01078675)
Timeframe: Serial blood samples over 24 hours.
| Intervention | ng/mL (Mean) |
|---|
| Rosuvastatin | 3.5717 |
Single Dose PK - Tmax
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing (NCT01078675)
Timeframe: Serial blood samples over 24 hours
| Intervention | hr (Mean) |
|---|
| Rosuvastatin | 2.664 |
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories. (NCT01105975)
Timeframe: Baseline through Week 12
| Intervention | events (Number) |
|---|
| High Risk (HR)- Angioedema | HR - Insufficient Documentation for Determination | Low Risk | Not a Relevant Dermatoses | Insufficient Documentation for Determination |
|---|
| 10 mg Rosuvastatin Monotherapy | 0 | 0 | 0 | 0 | 0 |
,| 100 mg LY2484595 + 10 mg Rosuvastatin | 0 | 1 | 2 | 1 | 0 |
,| 100 mg LY2484595 + 20 mg Atorvastatin | 0 | 0 | 0 | 2 | 0 |
,| 100 mg LY2484595 + 40 mg Simvastatin | 0 | 0 | 1 | 4 | 0 |
,| 100 mg LY2484595 Monotherapy | 0 | 0 | 0 | 5 | 0 |
,| 20 mg Atorvastatin Monotherapy | 0 | 0 | 0 | 1 | 0 |
,| 30 mg LY2484595 Monotherapy | 0 | 0 | 0 | 4 | 0 |
,| 40 mg Simvastatin Monotherapy | 1 | 0 | 0 | 6 | 0 |
,| 500 mg LY2484595 Monotherapy | 0 | 0 | 0 | 3 | 0 |
,| Placebo | 0 | 0 | 0 | 0 | 0 |
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of picomoles/mL/minute (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | -49.48 |
| 100 mg LY2484595 Monotherapy | -70.80 |
| 500 mg LY2484595 Monotherapy | -89.10 |
| Placebo | 12.12 |
| 20 mg Atorvastatin Monotherapy | -0.01 |
| 100 mg LY2484595 + 20 mg Atorvastatin | -72.00 |
| 40 mg Simvastatin Monotherapy | -2.23 |
| 100 mg LY2484595 + 40 mg Simvastatin | -64.64 |
| 10 mg Rosuvastatin Monotherapy | -7.19 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | -73.24 |
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | nanograms/milliliter/hour (ng/mL/h) (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | -0.06 |
| 100 mg LY2484595 Monotherapy | -0.11 |
| 500 mg LY2484595 Monotherapy | -0.58 |
| Placebo | -0.30 |
| 20 mg Atorvastatin Monotherapy | -0.58 |
| 100 mg LY2484595 + 20 mg Atorvastatin | -0.26 |
| 40 mg Simvastatin Monotherapy | -0.16 |
| 100 mg LY2484595 + 40 mg Simvastatin | 0.00 |
| 10 mg Rosuvastatin Monotherapy | -0.86 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | -0.29 |
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | nanogram/deciliter (ng/dL) (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | -0.5 |
| 100 mg LY2484595 Monotherapy | 1.0 |
| 500 mg LY2484595 Monotherapy | -0.3 |
| Placebo | -1.0 |
| 20 mg Atorvastatin Monotherapy | -1.0 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 0.4 |
| 40 mg Simvastatin Monotherapy | 0.0 |
| 100 mg LY2484595 + 40 mg Simvastatin | -1.7 |
| 10 mg Rosuvastatin Monotherapy | -2.5 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 0.0 |
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | milliequivalents/Liter (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 0.40 |
| 100 mg LY2484595 Monotherapy | 0.60 |
| 500 mg LY2484595 Monotherapy | 0.51 |
| Placebo | 0.27 |
| 20 mg Atorvastatin Monotherapy | 0.10 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 0.58 |
| 40 mg Simvastatin Monotherapy | 1.04 |
| 100 mg LY2484595 + 40 mg Simvastatin | 0.58 |
| 10 mg Rosuvastatin Monotherapy | 0.78 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 1.25 |
Change From Baseline to 12 Weeks Endpoint in Serum Potassium
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | milliequivalents/Liter (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | -0.04 |
| 100 mg LY2484595 Monotherapy | 0.01 |
| 500 mg LY2484595 Monotherapy | -0.02 |
| Placebo | -0.08 |
| 20 mg Atorvastatin Monotherapy | 0.09 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 0.08 |
| 40 mg Simvastatin Monotherapy | 0.03 |
| 100 mg LY2484595 + 40 mg Simvastatin | 0.02 |
| 10 mg Rosuvastatin Monotherapy | -0.07 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | -0.05 |
Change From Baseline to 12 Weeks Endpoint in Serum Sodium
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | milliequivalents/Liter (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 0.3 |
| 100 mg LY2484595 Monotherapy | 0.3 |
| 500 mg LY2484595 Monotherapy | 0.5 |
| Placebo | 0.1 |
| 20 mg Atorvastatin Monotherapy | 1.3 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 0.6 |
| 40 mg Simvastatin Monotherapy | 0.8 |
| 100 mg LY2484595 + 40 mg Simvastatin | 0.9 |
| 10 mg Rosuvastatin Monotherapy | 0.5 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 0.3 |
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline up to Week 18
| Intervention | units on a scale (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 0.008 |
| 100 mg LY2484595 Monotherapy | 0.002 |
| 500 mg LY2484595 Monotherapy | 0.012 |
| Placebo | -0.001 |
| 20 mg Atorvastatin Monotherapy | -0.002 |
| 100 mg LY2484595 + 20 mg Atorvastatin | -0.006 |
| 40 mg Simvastatin Monotherapy | -0.001 |
| 100 mg LY2484595 + 40 mg Simvastatin | -0.001 |
| 10 mg Rosuvastatin Monotherapy | 0.014 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | -0.047 |
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 53.6 |
| 100 mg LY2484595 Monotherapy | 94.6 |
| 500 mg LY2484595 Monotherapy | 128.8 |
| Placebo | -3.0 |
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 20 mg Atorvastatin Monotherapy | 1.4 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 79.9 |
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 40 mg Simvastatin Monotherapy | 7.3 |
| 100 mg LY2484595 + 40 mg Simvastatin | 86.6 |
| 10 mg Rosuvastatin Monotherapy | 5.5 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 94.0 |
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | -13.6 |
| 100 mg LY2484595 Monotherapy | -22.3 |
| 500 mg LY2484595 Monotherapy | -35.9 |
| Placebo | 3.9 |
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 20 mg Atorvastatin Monotherapy | -33.6 |
| 100 mg LY2484595 + 20 mg Atorvastatin | -47.6 |
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of mg/dL (Least Squares Mean) |
|---|
| 40 mg Simvastatin Monotherapy | -34.9 |
| 100 mg LY2484595 + 40 mg Simvastatin | -46.1 |
| 10 mg Rosuvastatin Monotherapy | -38.8 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | -52.3 |
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | percent change of micrograms/mL (mcg/mL) (Least Squares Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 63.94 |
| 100 mg LY2484595 Monotherapy | 92.27 |
| 500 mg LY2484595 Monotherapy | 136.66 |
| Placebo | 0.58 |
| 20 mg Atorvastatin Monotherapy | -11.8 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 62.98 |
| 40 mg Simvastatin Monotherapy | -11.14 |
| 100 mg LY2484595 + 40 mg Simvastatin | 65.92 |
| 10 mg Rosuvastatin Monotherapy | -16.58 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 64.08 |
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
(NCT01105975)
Timeframe: Baseline up to 12 weeks
| Intervention | nanograms*hour/milliliter (ng*h/mL) (Geometric Mean) |
|---|
| 30 mg LY2484595 Monotherapy | 2300 |
| 100 mg LY2484595 Monotherapy | 5900 |
| 500 mg LY2484595 Monotherapy | 19700 |
| 100 mg LY2484595 + 20 mg Atorvastatin | 5500 |
| 100 mg LY2484595 + 40 mg Simvastatin | 5620 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | 5960 |
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction. (NCT01105975)
Timeframe: Baseline, Week 12
| Intervention | millimeters of mercury (mmHg) (Least Squares Mean) |
|---|
| Diastolic BP | Systolic BP |
|---|
| 10 mg Rosuvastatin Monotherapy | 2.2 | 0.0 |
,| 100 mg LY2484595 + 10 mg Rosuvastatin | -0.1 | 3.8 |
,| 100 mg LY2484595 + 20 mg Atorvastatin | 1.2 | 2.1 |
,| 100 mg LY2484595 + 40 mg Simvastatin | 2.3 | 2.3 |
,| 100 mg LY2484595 Monotherapy | 0.8 | 4.3 |
,| 20 mg Atorvastatin Monotherapy | 0.2 | 0.2 |
,| 30 mg LY2484595 Monotherapy | 1.1 | 4.4 |
,| 40 mg Simvastatin Monotherapy | -1.5 | 0.0 |
,| 500 mg LY2484595 Monotherapy | 1.2 | 1.4 |
,| Placebo | 1.6 | 2.8 |
Percent Change From Baseline in Total Cholesterol (TC) (Phase I)
TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -13.6 |
| Phase I: Atorvastatin 20 mg | -6.3 |
| Rosuvastatin 10 mg | -8.2 |
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)
Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -0.6 |
| Phase I: Atorvastatin 20 mg | -1.9 |
| Rosuvastatin 10 mg | 1.4 |
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)
Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -11.2 |
| Phase II: Atorva 40mg | -6.4 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -11.2 |
| Phase II: Rosuvastatin 20mg | -5.4 |
| Phase II: EZ 10mg+Atorva 10mg | -6.7 |
Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)
Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -13.0 |
| Phase I: Atorvastatin 20 mg | -4.8 |
| Phase 1: Rosuvastatin 10 mg | -8.8 |
Percent Change From Baseline in Apo B (Phase II)
Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -12.0 |
| Phase II: Atorva 40mg | -6.3 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -14.0 |
| Phase II: Rosuvastatin 20mg | -4.9 |
| Phase II: EZ 10mg+Atorva 10mg | -4.0 |
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)
Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -18.2 |
| Phase II: Atorva 40mg | -8.8 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -16.3 |
| Phase II: Rosuvastatin 20mg | -5.9 |
| Phase II: EZ 10mg+Atorva 10mg | -1.9 |
Percent Change From Baseline in TC/HDL-C Ratio (Phase I)
TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -14.3 |
| Phase I: Atorvastatin 20 mg | -4.5 |
| Rosuvastatin 10 mg | -9.0 |
Percent Change From Baseline in TC/HDL-C Ratio (Phase II)
TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -13.5 |
| Phase II: Atorva 40mg | -6.5 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -11.7 |
| Phase II: Rosuvastatin 20mg | -4.0 |
| Phase II: EZ 10mg+Atorva 10mg | -1.0 |
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).
LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L). (NCT01154036)
Timeframe: Baseline (Week 6) and Week 12
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -16.4 |
| Phase II: Atorva 40mg | -8.1 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -19.3 |
| Phase II: Rosuvastatin 20mg | -8.4 |
| Phase II: EZ 10mg+Atorva 10mg | 2.4 |
Percent Change From Baseline in Total Cholesterol (TC) (Phase II)
TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -10.2 |
| Phase II: Atorva 40mg | -2.9 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -13.1 |
| Phase II: Rosuvastatin 20mg | -5.0 |
| Phase II: EZ 10mg+Atorva 10mg | 2.2 |
Percent Change From Baseline in Triglycerides (TG) (Phase I)
TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Least Squares Mean) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -6.0 |
| Phase I: Atorvastatin 20 mg | -3.9 |
| Rosuvastatin 10 mg | -1.1 |
Percent Change From Baseline in Triglycerides (TG) (Phase II)
TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Least Squares Mean) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -5.9 |
| Phase II: Atorva 40mg | -3.1 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -10.2 |
| Phase II: Rosuvastatin 20mg | -3.2 |
| Phase II: EZ 10mg+Atorva 10mg | NA |
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)
(NCT01154036)
Timeframe: Week 6 (End of Phase I)
| Intervention | Percentage of Participants (Number) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 56.3 |
| Phase I: Atorvastatin 20 mg | 37.4 |
| Rosuvastatin 10 mg | 43.6 |
Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)
(NCT01154036)
Timeframe: Week 12 (End of Phase II)
| Intervention | Percentage of Participants (Number) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | 55.8 |
| Phase II: Atorva 40mg | 34.1 |
| Phase II: EZ 10mg + Atorva 20mg [R] | 53.5 |
| Phase II: Rosuvastatin 20mg | 35.8 |
| Phase II: EZ 10mg+Atorva 10mg | NA |
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)
(NCT01154036)
Timeframe: Week 6 (End of Phase I)
| Intervention | Percentage of Participants (Number) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 19.3 |
| Phase I: Atorvastatin 20 mg | 3.0 |
| Rosuvastatin 10 mg | 6.6 |
Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)
(NCT01154036)
Timeframe: Week 12 (end of Phase II)
| Intervention | Percentage of Participants (Number) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | 18.3 |
| Phase II: Atorva 40mg | 0.8 |
| Phase II: EZ 10mg + Atorva 20mg [R] | 15.4 |
| Phase II: Rosuvastatin 20mg | 3.0 |
| Phase II: EZ 10mg+Atorva 10mg | NA |
Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)
Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -18.9 |
| Phase I: Atorvastatin 20 mg | -6.3 |
| Phase 1: Rosuvastatin 10 mg | -12.2 |
Percent Change From Baseline in Non-HDL-C (Phase II)
Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -17.5 |
| Phase II: Atorva 40mg | -5.5 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -18.1 |
| Phase II: Rosuvastatin 20mg | -6.3 |
| Phase II: EZ 10mg+Atorva 10mg | -0.5 |
Percent Change From Baseline in Non-HDL-C (Phase I)
Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -18.0 |
| Phase I: Atorvastatin 20 mg | -7.9 |
| Rosuvastatin 10 mg | -11.1 |
Percent Change From Baseline in Apo A-I (Phase II)
Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | 1.6 |
| Phase II: Atorva 40mg | 1.4 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -0.6 |
| Phase II: Rosuvastatin 20mg | 0.0 |
| Phase II: EZ 10mg+Atorva 10mg | -0.7 |
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)
LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L). (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I )
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -24.8 |
| Phase I: Atorvastatin 20 mg | -10.1 |
| Phase I: Rosuvastatin 10 mg | -13.8 |
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)
LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -20.6 |
| Phase II: Atorva 40mg | -8.2 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -18.2 |
| Phase II: Rosuvastatin 20mg | -7.5 |
| Phase II: EZ 10mg+Atorva 10mg | -4.5 |
Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)
LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -23.9 |
| Phase I: Atorvastatin 20 mg | -7.1 |
| Phase 1: Rosuvastatin 10 mg | -14.7 |
Percent Change From Baseline in Hs-CRP (Phase II)
hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Least Squares Mean) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | -19.5 |
| Phase II: Atorva 40mg | -6.4 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -10.9 |
| Phase II: Rosuvastatin 20mg | 0.7 |
| Phase II: EZ 10mg+Atorva 10mg | NA |
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)
hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Least Squares Mean) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -10.5 |
| Phase I: Atorvastatin 20 mg | -6.6 |
| Phase I: Rosuvastatin 10 mg | -9.0 |
Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)
HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | 0.9 |
| Phase I: Atorvastatin 20 mg | -1.3 |
| Rosuvastatin 10 mg | 1.0 |
Percent Change From Baseline in HDL-C (Phase II)
HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. (NCT01154036)
Timeframe: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)
| Intervention | Percentage Change (Median) |
|---|
| Phase II: EZ 10mg + Atorva 20mg [A] | 0.9 |
| Phase II: Atorva 40mg | 1.0 |
| Phase II: EZ 10mg + Atorva 20mg [R] | -0.8 |
| Phase II: Rosuvastatin 20mg | 0.0 |
| Phase II: EZ 10mg+Atorva 10mg | 0.0 |
Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)
Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 (NCT01154036)
Timeframe: Baseline and Week 6 (end of Phase I)
| Intervention | Percentage Change (Median) |
|---|
| Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg | -12.1 |
| Phase I: Atorvastatin 20 mg | -6.1 |
| Rosuvastatin 10 mg | -7.6 |
Percent Mean Change From Baseline of International Normalized Ratio (INR)
INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI) (NCT01178853)
Timeframe: 22 Days
| Intervention | percent change (Mean) |
|---|
| Warfarin + Pitavastatin | 0.0452 |
| Warfarin + Rosuvastatin | 0.1605 |
Carotid IMT
changes in carotid IMT is a good measure for cardiovascular disease progression (NCT01218802)
Timeframe: 96 weeks
| Intervention | percentage change (Mean) |
|---|
| Rosuvastatin | 1.21 |
| Sugar Pill Placebo | 4.04 |
Bone Mineral Density (BMD)
Measured by change in bone DEXA from baseline to week 96 (NCT01218802)
Timeframe: 96 weeks
| Intervention | percentage of change (Mean) |
|---|
| Rosuvastatin | -0.03 |
| Sugar Pill Placebo | -0.53 |
Platelet - Leukocyte Aggregates
measured by flow cytometry (NCT01241903)
Timeframe: within first 24 hours
| Intervention | % leukocytes with platelets attached (Mean) |
|---|
| Baseline | 8 Hour | 24 Hour |
|---|
| Placebo | 29.2 | 26.2 | 24.4 |
,| Rosuvastatin | 39.8 | 21.1 | 21.3 |
Mean Change of Tissue Factor Bearing Microparticles
Comparison of plasma microparticle concentration between baseline and week 4 (NCT01299038)
Timeframe: 4 weeks
| Intervention | microparticles per microliter (Mean) |
|---|
| Rosuvastatin 20mg | 102 |
| Rosuvastatin 40mg | -618 |
Reduction of LDL Cholesterol Levels
The primary efficacy variable was the percentage of LDL-C variation at the end of nine weeks of treatment, compared to baseline (pre-randomization), in participants who achieved LDL <100 mg/dL were considered to have been successfully treated. (NCT01420549)
Timeframe: Baseline compared to the end of 9 weeks of treatment
| Intervention | percent change of LDL (Least Squares Mean) |
|---|
| Rosuvastatin + Ezetimibe | -39.45 |
| Simvastatin + Ezetimibe | -29.13 |
Change From Baseline in 1,5-AG Level
An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa (NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
| Intervention | μg/mL (Mean) |
|---|
| At 3 months | At 6 months | At 12 months | Baseline 1,5-AG level |
|---|
| Atorvastatin Administration Group | -0.51 | -1.28 | -0.88 | 15.40 |
,| Rosuvastatin Administration Group | -0.21 | -0.94 | -1.09 | 15.39 |
Change in HbA1c Level
(NCT01544309)
Timeframe: Baseline, 12 months after administration
| Intervention | Amount of change (%) (Mean) |
|---|
| Atorvastatin Administration Group | 0.120 |
| Rosuvastatin Administration Group | 0.10 |
Percent Change in Non-HDL-C Level
(NCT01544309)
Timeframe: Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment
| Intervention | Percent change (Mean) |
|---|
| At 3 months | At 6 months |
|---|
| Atorvastatin Administration Group | -33.8 | -33.2 |
,| Rosuvastatin Administration Group | -35.5 | -33.5 |
Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007
Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented. (NCT01544309)
Timeframe: 3 months after administration, the end of starting dose and the end of study treatment
| Intervention | Percentage of participants (Number) |
|---|
| At 3 months | At the end of study treatment |
|---|
| Atorvastatin Administration Group | 89.0 | 86.3 |
,| Rosuvastatin Administration Group | 89.9 | 87.5 |
Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)
(NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
| Intervention | Percent change (Mean) |
|---|
| LDL-C: at 3 months | LDL-C: at 6 months | LDL-C: at 12 months | HDL-C: at 3 months | HDL-C: at 6 months | HDL-C: at 12 months | TC: at 3 months | TC: at 6 months | TC: at 12 months | TG at 3 months | TG: at 6 months | TG: at 12 months | Non-HDL-C/HDL-C ratio: at 3 months | Non-HDL-C/HDL-C ratio: at 6 months | Non-HDL-C/HDL-C ratio: at 12 months | FFA: at 3 months | FFA: at 6 months | FFA: at 12 months |
|---|
| Atorvastatin Administration Group | -36.6 | -35.6 | -33.2 | 4.1 | 7.1 | 4.9 | -24.7 | -23.5 | -22.7 | -12.7 | -12.4 | -12.6 | -34.8 | -36.1 | -33.1 | 19.9 | 13.8 | 37.2 |
,| Rosuvastatin Administration Group | -39.2 | -36.4 | -34.7 | 5.6 | 8.2 | 7.7 | -25.9 | -23.8 | -23.5 | -11.0 | -11.9 | -15.9 | -37.7 | -37.2 | -36.0 | 25.9 | 15.9 | 34.8 |
Percent Change in Insulin Level
An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa. (NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
| Intervention | Percent change (Mean) |
|---|
| At 3 months | At 6 months | At 12 months |
|---|
| Atorvastatin Administration Group | 40.7 | 45.1 | 17.4 |
,| Rosuvastatin Administration Group | 31.3 | 35.5 | 13.8 |
Percent Change in Blood Glucose Level (Fasting)
(NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
| Intervention | Percent change (Mean) |
|---|
| At 3 months | At 6 months | At 12 months |
|---|
| Atorvastatin Administration Group | 3.3 | 7.0 | 4.6 |
,| Rosuvastatin Administration Group | 2.7 | 5.9 | 3.7 |
Frequency of Serious Adverse Events (SAE)
(NCT01544309)
Timeframe: Up to 12 months
| Intervention | Number of patients with SAE (Number) |
|---|
| Atorvastatin Administration Group | 14 |
| Rosuvastatin Administration Group | 19 |
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
(NCT01544309)
Timeframe: Baseline, and 12 months after administration
| Intervention | Percent change (Mean) |
|---|
| Atorvastatin Administration Group | -31.3 |
| Rosuvastatin Administration Group | -32.8 |
Percent Change in 1,5-AG Level
An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa (NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
| Intervention | Percent change (Mean) |
|---|
| At 3 months | At 6 months | At 12 months |
|---|
| Atorvastatin Administration Group | -1.6 | -6.5 | -3.8 |
,| Rosuvastatin Administration Group | 5.5 | 2.6 | 3.5 |
Change From Baseline in Insulin Level
An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa (NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
| Intervention | μU/mL (Mean) |
|---|
| At 3 months | At 6 months | At 12 months | Baseline Insulin level |
|---|
| Atorvastatin Administration Group | -0.10 | 0.66 | -1.50 | 10.95 |
,| Rosuvastatin Administration Group | -0.54 | -0.44 | -2.91 | 12.57 |
Change in Blood Glucose Level (Fasting)
(NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
| Intervention | mg/dL (Mean) |
|---|
| At 3 months | At 6 months | At 12 months |
|---|
| Atorvastatin Administration Group | 2.6 | 6.8 | 3.6 |
,| Rosuvastatin Administration Group | 0.1 | 4.3 | 1.5 |
Change in HbA1c Level
(NCT01544309)
Timeframe: Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
| Intervention | Amount of change (%) (Mean) |
|---|
| At 3 months | At 6 months |
|---|
| Atorvastatin Administration Group | 0.05 | 0.13 |
,| Rosuvastatin Administration Group | 0.00 | 0.12 |
Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status
"Deterioration of diabetic treatment status is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%." (NCT01544309)
Timeframe: Baseline, 3, 6, 12 months after administration
| Intervention | participants (Number) |
|---|
| Therapy intensification: 0-3 months | Therapy intensification: 3-6 months | Therapy intensification: 6-12 months | Other: 0-3 months | Other: 3-6 months | Other: 6-12 months | No deterioration |
|---|
| Atorvastatin Administration Group | 20 | 12 | 32 | 6 | 5 | 8 | 421 |
,| Rosuvastatin Administration Group | 14 | 8 | 23 | 5 | 5 | 6 | 453 |
Occurrence of Deterioration of Diabetic Treatment Status
"Deterioration of diabetic treatment status is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%." (NCT01544309)
Timeframe: Baseline, 12 months after administration
| Intervention | Participants (Number) |
|---|
| Therapy intensification | Deterioration in HbA1c of > 0.5% |
|---|
| Atorvastatin Administration Group | 64 | 177 |
,| Rosuvastatin Administration Group | 45 | 162 |
Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)
(NCT01544309)
Timeframe: From the start of the treatment to the end of study treatment
| Intervention | Number of patients with any events (Number) |
|---|
| Atorvastatin Administration Group | 5 |
| Rosuvastatin Administration Group | 9 |
Intravascular Ultrasound (IVUS) Parameters
"Change in atheroma volume and lumen CSA on IVUS as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention.~Data not analyzed. Data not available." (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | mm^2 (Mean) |
|---|
| Baseline Total atheroma volume | 6-8 weeks Total atheroma volume | Baseline Lumen CSA | 6-8 weeks Lumen CSA |
|---|
| Aggressive Lipid Therapy | 195.8 | 209.6 | 2.5 | 2.5 |
,| Standard of Care Lipid Therapy | 193.7 | 199.6 | 2.4 | 2.4 |
Fractional Flow Reserve (FFR) Value
Change in FFR as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow, is a lesion-specific index of stenosis severity that can be calculated by simultaneous measurement of mean arterial, distal coronary, and central venous pressure. (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | ratio (Mean) |
|---|
| Baseline | Follow-up |
|---|
| Aggressive Lipid Therapy | 0.73 | 0.75 |
,| Standard of Care Lipid Therapy | 0.73 | 0.73 |
Blood Chemistry - HsCRP
Correlation of yellow plaque index with changes in levels of blood HsCRP as compared from baseline to 6-8 weeks after intervention (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | mg/l (Median) |
|---|
| Baseline | Follow-Up |
|---|
| Aggressive Lipid Therapy | 1.7 | 1.2 |
,| Standard of Care Lipid Therapy | 1.7 | 1.9 |
Post PCI Cardiac Enzymes
Correlation of yellow plaque index with post procedure CK-MB, Troponin-I release. (NCT01567826)
Timeframe: at 6-8 weeks after intervention
| Intervention | ng/mL (Mean) |
|---|
| CK-MB | Troponin-I |
|---|
| Aggressive Lipid Therapy | 3.7 | 0.3 |
,| Standard of Care Lipid Therapy | 5.1 | 0.4 |
Lipiscan - Lipid Core Burden Index (LCBI)
The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison. (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | ratio (Median) |
|---|
| Baseline LCBI, lesion | Follow-up LCBI, lesion |
|---|
| Aggressive Lipid Therapy | 132.4 | 99.8 |
,| Standard of Care Lipid Therapy | 95.4 | 99.9 |
LCBI4mm Max
LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison. (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | ratio (Median) |
|---|
| Baseline LCBI4mm max | Follow-up LCBI4mm max |
|---|
| Aggressive Lipid Therapy | 490.6 | 336.1 |
,| Standard of Care Lipid Therapy | 356.7 | 385.7 |
Change in LCBI, Lesion
Change in LCBI at 6-8 weeks after intervention as compared to baseline (NCT01567826)
Timeframe: at baseline and at 6-8 weeks post intervention
| Intervention | ratio (Median) |
|---|
| Standard of Care Lipid Therapy | 8.0 |
| Aggressive Lipid Therapy | -22.5 |
Change in LCBI4mm Max
Change in LCBI4mm max at 6-8 weeks after intervention as compared to baseline. LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. (NCT01567826)
Timeframe: at baseline and at 6-8 weeks after intervention
| Intervention | ratio (Median) |
|---|
| Standard of Care Lipid Therapy | 2.4 |
| Aggressive Lipid Therapy | -149.1 |
Major Adverse Cardiac Events (MACE)
MACE defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days and 1 year. Details reported in adverse events section. (NCT01567826)
Timeframe: at 6-8 weeks after intervention
| Intervention | participants (Number) |
|---|
| Standard of Care Lipid Therapy | 2 |
| Aggressive Lipid Therapy | 3 |
Diameter Stenosis
Percentage stenosis of vessel diameter in the analysis segment of nontarget lesions as measured by angiography that remained >70%, after successful PCI of the target lesion. (NCT01567826)
Timeframe: Baseline and 6-8 weeks post intervention
| Intervention | percentage of lesions (Number) |
|---|
| Baseline | Follow-up |
|---|
| Aggressive Lipid Therapy | 79.6 | 79.4 |
,| Standard of Care Lipid Therapy | 79.9 | 83 |
Changes in Major Lipid Parameters - VLDL Size
Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size. (NCT01660191)
Timeframe: Change from Baseline to 12 Weeks
| Intervention | nanometre (nm) (Mean) |
|---|
| Atorvastatin 20mg | 0.68 |
| Pitavastatin 4mg | 0.81 |
| Rosuvastatin 5 mg | 3.17 |
Changes in Plasma CoQ10 Levels
Change in levels will be measured by taking difference between Baseline and Week 12 measures. (NCT01660191)
Timeframe: Change from Baseline to 12 Weeks
| Intervention | μg/g (Mean) |
|---|
| Ubiquinone | Total CoQ10 | Upiquinol |
|---|
| Atorvastatin 20mg | -96.70 | -721.09 | -624.39 |
,| Pitavastatin 4mg | -110.42 | -464.85 | -354.43 |
,| Rosuvastatin 5 mg | -103.91 | -642.43 | -538.52 |
Changes HDL Particle Number and LDL Particle Number
Change in levels will be measured by difference in levels at 12 weeks. (NCT01660191)
Timeframe: Change from Baseline to 12 Weeks
| Intervention | particle number (Mean) |
|---|
| HDL Particle Number | LDL Particle Number |
|---|
| Atorvastatin 20mg | 0.64 | -873.48 |
,| Pitavastatin 4mg | 2.55 | -768.26 |
,| Rosuvastatin 5 mg | 2.05 | -626.61 |
Changes in HDL and LDL Size
Change in levels will be measured by difference in levels at 12 weeks (NCT01660191)
Timeframe: Change from Baseline to 12 Weeks
| Intervention | nanometre (nm) (Mean) |
|---|
| HDL Size | LDL Size |
|---|
| Atorvastatin 20mg | 0.23 | -0.02 |
,| Pitavastatin 4mg | 0.23 | -0.11 |
,| Rosuvastatin 5 mg | 0.12 | -0.09 |
Phosphocreatine Recovery
Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity (NCT01702987)
Timeframe: 1 month
| Intervention | percentage change from baseline (Mean) |
|---|
| Statin + Placebo | -18.9 |
| Statin + Ubiquinol | 7.7 |
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -10.4 |
| Placebo | 0.5 |
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -8.1 |
| Placebo | 0.6 |
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off treatment (ITT analysis). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -50.3 |
| Placebo | 8.4 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -49.4 |
| Placebo | 2.7 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis
Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least- squares (LS) means and standard errors at Week 24 were obtained from a mixed -effect model with repeated measures (MMRM) to account for missing data. All available post -baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -48.7 |
| Placebo | 2.8 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis
Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -44.2 |
| Placebo | 4.6 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -43.8 |
| Placebo | 4.6 |
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -42.8 |
| Placebo | -3.5 |
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -43.2 |
| Placebo | -3.5 |
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -35.4 |
| Placebo | -0.9 |
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | 2.8 |
| Placebo | -1.6 |
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | 0.4 |
| Placebo | -1.9 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01709500)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab 75 mg/up to 150 mg | 81.4 |
| Placebo | 11.3 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL--C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis). (NCT01709500)
Timeframe: Up to week 52
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab 75 mg/up to 150 mg | 82.1 |
| Placebo | 11.6 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01709500)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab 75 mg/up to 150 mg | 68.2 |
| Placebo | 1.2 |
Percentage of Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis
Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis). (NCT01709500)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab 75 mg/up to 150 mg | 68.8 |
| Placebo | 1.3 |
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -26.6 |
| Placebo | 3.4 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -30.6 |
| Placebo | 2.1 |
Percent Change From Baseline in Non-High -Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -42.6 |
| Placebo | 3.1 |
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -43.2 |
| Placebo | 3.1 |
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -37.9 |
| Placebo | 4.1 |
Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -30.3 |
| Placebo | -10 |
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | -24.7 |
| Placebo | -5.6 |
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | 6.0 |
| Placebo | -0.8 |
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment. (NCT01709500)
Timeframe: From Baseline to Week 52
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab 75 mg/up to 150 mg | 6.0 |
| Placebo | -0.8 |
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Atorvastatin 40 mg | -11.7 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -5.4 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -24.0 |
| Atorvastatin 80 mg | -1.6 |
| Rosuvastatin 40 mg | 11.5 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 7.9 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -27.9 |
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Atorvastatin 40 mg | -20.2 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -10.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -23.6 |
| Atorvastatin 80 mg | -9.7 |
| Rosuvastatin 40 mg | -4.9 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 0.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -30.8 |
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -7.1 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -17.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -40.6 |
| Atorvastatin 80 mg | -13.0 |
| Rosuvastatin 40 mg | -19.8 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -27.5 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -42.3 |
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -7.5 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -18.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -40.5 |
| Atorvastatin 80 mg | -7.0 |
| Rosuvastatin 40 mg | -18.4 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -23.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -50.5 |
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -6.3 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -15.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -36.7 |
| Atorvastatin 80 mg | -6.5 |
| Rosuvastatin 40 mg | -17.4 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -21.0 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -47.6 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -4.0 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -11.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -27.1 |
| Atorvastatin 80 mg | -4.8 |
| Rosuvastatin 40 mg | -11.7 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -15.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -33.6 |
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | 1.9 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -0.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 4.8 |
| Atorvastatin 80 mg | 4.7 |
| Rosuvastatin 40 mg | 5.7 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 2.0 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 7.7 |
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -6.5 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -13.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -29.0 |
| Atorvastatin 80 mg | -9.9 |
| Rosuvastatin 40 mg | -13.5 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -19.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -29.0 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01730040)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin 40 mg | 16.0 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 50.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 79.2 |
| Atorvastatin 80 mg | 10.2 |
| Rosuvastatin 40 mg | 42.2 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 54.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 77.2 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis). (NCT01730040)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin 40 mg | 20.0 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 55.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 82.3 |
| Atorvastatin 80 mg | 10.5 |
| Rosuvastatin 40 mg | 42.4 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 55.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 83.7 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01730040)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin 40 mg | 34.5 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 68.4 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 87.2 |
| Atorvastatin 80 mg | 18.5 |
| Rosuvastatin 40 mg | 62.2 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 65.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 84.6 |
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -6.9 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -13.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -38.4 |
| Atorvastatin 80 mg | -9.5 |
| Rosuvastatin 40 mg | -14.1 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -20.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -36.2 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis). (NCT01730040)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin 40 mg | 37.8 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 72.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 91.2 |
| Atorvastatin 80 mg | 18.5 |
| Rosuvastatin 40 mg | 64.0 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 66.2 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 90.0 |
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -3.2 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -1.7 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 4.1 |
| Atorvastatin 80 mg | 3.0 |
| Rosuvastatin 40 mg | 4.6 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 4.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 8.5 |
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Atorvastatin 40 mg | -6.7 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -3.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -12.0 |
| Atorvastatin 80 mg | -7.3 |
| Rosuvastatin 40 mg | -0.5 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -13.9 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -19.1 |
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Atorvastatin 40 mg | -4.7 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 0.5 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -12.4 |
| Atorvastatin 80 mg | -4.6 |
| Rosuvastatin 40 mg | -3.7 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -16.8 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -12.1 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -6.1 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -23.7 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -48.6 |
| Atorvastatin 80 mg | -5.0 |
| Rosuvastatin 40 mg | -22.9 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -24.5 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -57.8 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -5 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -20.5 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -44.1 |
| Atorvastatin 80 mg | -4.8 |
| Rosuvastatin 40 mg | -21.4 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -22.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -54 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -9.2 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -27.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -53.7 |
| Atorvastatin 80 mg | -14.6 |
| Rosuvastatin 40 mg | -23.3 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -30.7 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -50.9 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -8.5 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -22.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -48.4 |
| Atorvastatin 80 mg | -14.5 |
| Rosuvastatin 40 mg | -23.3 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -29.7 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -50.5 |
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -4.4 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -10.1 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -33.7 |
| Atorvastatin 80 mg | -3.5 |
| Rosuvastatin 40 mg | -10.9 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -14.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -41.9 |
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first). (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -5.1 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | -12.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -37.7 |
| Atorvastatin 80 mg | -4.4 |
| Rosuvastatin 40 mg | -12.8 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -16.3 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -42.7 |
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | 1.2 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 1.0 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 7.6 |
| Atorvastatin 80 mg | 2.2 |
| Rosuvastatin 40 mg | 4.7 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | -1.8 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 5.8 |
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730040)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Atorvastatin 40 mg | -0.8 |
| Ezetimibe 10 mg + Atorvastatin 20 mg | 1.7 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 5.4 |
| Atorvastatin 80 mg | 1.6 |
| Rosuvastatin 40 mg | 5.6 |
| Ezetimibe 10 mg + Atorvastatin 40 mg | 1.6 |
| Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 9.4 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01730053)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin 20 mg | 45.0 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 57.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 84.9 |
| Rosuvastatin 40 mg | 40.1 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 52.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 66.7 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis). (NCT01730053)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin 20 mg | 34.8 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 46.7 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 76.5 |
| Rosuvastatin 40 mg | 30.6 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 45.1 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 66.1 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis). (NCT01730053)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin 20 mg | 31.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 43.1 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 77.8 |
| Rosuvastatin 40 mg | 29.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 43.6 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 60.1 |
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -8.9 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -11.8 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -29.0 |
| Rosuvastatin 40 mg | -13.8 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -13.9 |
| Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg | -19.4 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -8.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -8.7 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -28.9 |
| Rosuvastatin 40 mg | -8.5 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -12.4 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -20.6 |
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first). (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -12.9 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -17.5 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -45.7 |
| Rosuvastatin 40 mg | -14.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -18.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -35.6 |
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -11.7 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -16.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -41.2 |
| Rosuvastatin 40 mg | -18.0 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -18.7 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -29.8 |
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin 20 mg | -4.0 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -4.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -27.9 |
| Rosuvastatin 40 mg | -5.2 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -5.8 |
| Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg | -22.7 |
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin 20 mg | -0.7 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -3.9 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -20.7 |
| Rosuvastatin 40 mg | 3.5 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 7.9 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -16.0 |
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -11.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -13.4 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -42.7 |
| Rosuvastatin 40 mg | -11.2 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -12.9 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -31.4 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis). (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -18.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -20.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -53.5 |
| Rosuvastatin 40 mg | -17.0 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -16.5 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -41.5 |
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -16.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -14.4 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -50.6 |
| Rosuvastatin 40 mg | -15.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -11.0 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -36.3 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis). (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -17.2 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -20.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -52.6 |
| Rosuvastatin 40 mg | -22.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -21.8 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -35.1 |
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis). (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -17.1 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -17.4 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -49.6 |
| Rosuvastatin 40 mg | -22.1 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -19.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -32.3 |
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -7.3 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -9.7 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -36.5 |
| Rosuvastatin 40 mg | -9.8 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -11.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -28.3 |
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first). (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -8.8 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -11.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -39.5 |
| Rosuvastatin 40 mg | -12.7 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -12.6 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -30.4 |
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | -8.1 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -12.1 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -36.1 |
| Rosuvastatin 40 mg | -13.7 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -14.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -29.0 |
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | 5.4 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 5.0 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 6.7 |
| Rosuvastatin 40 mg | 2.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -0.9 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 6.7 |
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | 4.0 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 2.6 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 4.3 |
| Rosuvastatin 40 mg | 0.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 1.8 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 9.1 |
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis). (NCT01730053)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Rosuvastatin 20 mg | 47.0 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 60.5 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 86.4 |
| Rosuvastatin 40 mg | 41.3 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 54.8 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 70.4 |
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin 20 mg | -1.8 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -8.3 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -11.2 |
| Rosuvastatin 40 mg | -9.9 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -11.1 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -8.7 |
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Mean) |
|---|
| Rosuvastatin 20 mg | 8.1 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | -8.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | -14 |
| Rosuvastatin 40 mg | -2.7 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -12.4 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | -10.1 |
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | 0.7 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 0.2 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 5.9 |
| Rosuvastatin 40 mg | 0.6 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | 3.1 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 8.0 |
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT01730053)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Rosuvastatin 20 mg | 1.7 |
| Ezetimibe 10 mg + Rosuvastatin 10 mg | 4.0 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg | 9.1 |
| Rosuvastatin 40 mg | 1.5 |
| Ezetimibe 10 mg + Rosuvastatin 20 mg | -1.8 |
| Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg | 7.2 |
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
(NCT01763866)
Timeframe: Week 12
| Intervention | percentage of participants (Number) |
|---|
| A10 PBO Q2W | 2.0 |
| A10 PBO QM | 5.9 |
| A10 EZE (Q2W) | 22.4 |
| A10 EZE (QM) | 19.2 |
| A10 EvoMab Q2W | 85.4 |
| A10 EvoMab QM | 84.2 |
| A80 PBO Q2W | 13.0 |
| A80 PBO QM | 9.8 |
| A80 EZE (Q2W) | 52.0 |
| A80 EZE (QM) | 55.8 |
| A80 EvoMab Q2W | 93.1 |
| A80 EvoMab QM | 91.0 |
| R5 PBO Q2W | 7.7 |
| R5 PBO QM | 5.5 |
| R5 EvoMab Q2W | 85.0 |
| R5 EvoMab QM | 86.5 |
| R40 PBO Q2W | 39.6 |
| R40 PBO QM | 28.0 |
| R40 EvoMab Q2W | 92.3 |
| R40 EvoMab QM | 92.3 |
| S40 PBO Q2W | 1.9 |
| S40 PBO QM | 6.4 |
| S40 EvoMab Q2W | 94.4 |
| S40 EvoMab QM | 84.8 |
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
(NCT01763866)
Timeframe: Weeks 10 and 12
| Intervention | percentage of participants (Number) |
|---|
| A10 PBO Q2W | 5.7 |
| A10 PBO QM | 5.6 |
| A10 EZE (Q2W) | 20.0 |
| A10 EZE (QM) | 16.7 |
| A10 EvoMab Q2W | 88.1 |
| A10 EvoMab QM | 85.8 |
| A80 PBO Q2W | 13.7 |
| A80 PBO QM | 9.3 |
| A80 EZE (Q2W) | 50.9 |
| A80 EZE (QM) | 62.3 |
| A80 EvoMab Q2W | 94.4 |
| A80 EvoMab QM | 92.5 |
| R5 PBO Q2W | 7.0 |
| R5 PBO QM | 5.3 |
| R5 EvoMab Q2W | 88.7 |
| R5 EvoMab QM | 89.9 |
| R40 PBO Q2W | 38.9 |
| R40 PBO QM | 28.8 |
| R40 EvoMab Q2W | 93.5 |
| R40 EvoMab QM | 94.5 |
| S40 PBO Q2W | 1.9 |
| S40 PBO QM | 3.9 |
| S40 EvoMab Q2W | 93.6 |
| S40 EvoMab QM | 88.5 |
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 8.32 |
| A10 PBO QM | 14.74 |
| A10 EZE (Q2W) | -4.61 |
| A10 EZE (QM) | 3.45 |
| A10 EvoMab Q2W | -6.16 |
| A10 EvoMab QM | -11.73 |
| A80 PBO Q2W | 6.73 |
| A80 PBO QM | 8.54 |
| A80 EZE (Q2W) | -7.92 |
| A80 EZE (QM) | -6.00 |
| A80 EvoMab Q2W | -9.69 |
| A80 EvoMab QM | -1.06 |
| R5 PBO Q2W | 13.79 |
| R5 PBO QM | 12.47 |
| R5 EvoMab Q2W | -8.20 |
| R5 EvoMab QM | -6.28 |
| R40 PBO Q2W | 10.09 |
| R40 PBO QM | 8.59 |
| R40 EvoMab Q2W | -6.10 |
| R40 EvoMab QM | -9.95 |
| S40 PBO Q2W | 7.63 |
| S40 PBO QM | 20.97 |
| S40 EvoMab Q2W | -14.83 |
| S40 EvoMab QM | -15.86 |
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.51 |
| A10 PBO QM | 9.53 |
| A10 EZE (Q2W) | -5.35 |
| A10 EZE (QM) | 1.77 |
| A10 EvoMab Q2W | -6.85 |
| A10 EvoMab QM | -11.77 |
| A80 PBO Q2W | 6.24 |
| A80 PBO QM | 8.31 |
| A80 EZE (Q2W) | -8.52 |
| A80 EZE (QM) | -6.13 |
| A80 EvoMab Q2W | -8.96 |
| A80 EvoMab QM | -6.38 |
| R5 PBO Q2W | 12.86 |
| R5 PBO QM | 12.54 |
| R5 EvoMab Q2W | -12.22 |
| R5 EvoMab QM | -7.25 |
| R40 PBO Q2W | 7.06 |
| R40 PBO QM | 8.13 |
| R40 EvoMab Q2W | -9.09 |
| R40 EvoMab QM | -15.05 |
| S40 PBO Q2W | 8.64 |
| S40 PBO QM | 16.37 |
| S40 EvoMab Q2W | -14.57 |
| S40 EvoMab QM | -16.50 |
Percent Change From Baseline in Triglycerides at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 8.27 |
| A10 PBO QM | 14.35 |
| A10 EZE (Q2W) | -0.43 |
| A10 EZE (QM) | 4.88 |
| A10 EvoMab Q2W | -3.79 |
| A10 EvoMab QM | -13.26 |
| A80 PBO Q2W | 6.65 |
| A80 PBO QM | 8.22 |
| A80 EZE (Q2W) | -7.40 |
| A80 EZE (QM) | -3.11 |
| A80 EvoMab Q2W | -10.07 |
| A80 EvoMab QM | -1.10 |
| R5 PBO Q2W | 13.57 |
| R5 PBO QM | 12.96 |
| R5 EvoMab Q2W | -4.46 |
| R5 EvoMab QM | -6.88 |
| R40 PBO Q2W | 10.97 |
| R40 PBO QM | 10.00 |
| R40 EvoMab Q2W | -5.58 |
| R40 EvoMab QM | -10.51 |
| S40 PBO Q2W | 8.07 |
| S40 PBO QM | 16.72 |
| S40 EvoMab Q2W | -13.71 |
| S40 EvoMab QM | -14.65 |
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.49 |
| A10 PBO QM | 9.17 |
| A10 EZE (Q2W) | -3.16 |
| A10 EZE (QM) | 1.57 |
| A10 EvoMab Q2W | -5.61 |
| A10 EvoMab QM | -13.38 |
| A80 PBO Q2W | 6.16 |
| A80 PBO QM | 8.05 |
| A80 EZE (Q2W) | -8.10 |
| A80 EZE (QM) | -4.86 |
| A80 EvoMab Q2W | -9.27 |
| A80 EvoMab QM | -6.36 |
| R5 PBO Q2W | 12.43 |
| R5 PBO QM | 12.26 |
| R5 EvoMab Q2W | -10.28 |
| R5 EvoMab QM | -7.26 |
| R40 PBO Q2W | 8.44 |
| R40 PBO QM | 10.75 |
| R40 EvoMab Q2W | -9.15 |
| R40 EvoMab QM | -15.43 |
| S40 PBO Q2W | 9.29 |
| S40 PBO QM | 13.78 |
| S40 EvoMab Q2W | -11.67 |
| S40 EvoMab QM | -15.93 |
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.09 |
| A10 PBO QM | 2.80 |
| A10 EZE (Q2W) | -12.14 |
| A10 EZE (QM) | -9.85 |
| A10 EvoMab Q2W | -40.74 |
| A10 EvoMab QM | -40.07 |
| A80 PBO Q2W | 4.31 |
| A80 PBO QM | 6.18 |
| A80 EZE (Q2W) | -10.53 |
| A80 EZE (QM) | -11.06 |
| A80 EvoMab Q2W | -40.79 |
| A80 EvoMab QM | -36.25 |
| R5 PBO Q2W | 4.68 |
| R5 PBO QM | 6.07 |
| R5 EvoMab Q2W | -38.57 |
| R5 EvoMab QM | -39.26 |
| R40 PBO Q2W | 5.96 |
| R40 PBO QM | 2.69 |
| R40 EvoMab Q2W | -35.17 |
| R40 EvoMab QM | -32.30 |
| S40 PBO Q2W | -0.20 |
| S40 PBO QM | 5.13 |
| S40 EvoMab Q2W | -47.24 |
| S40 EvoMab QM | -39.47 |
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 5.96 |
| A10 PBO QM | 2.24 |
| A10 EZE (Q2W) | -14.39 |
| A10 EZE (QM) | -10.86 |
| A10 EvoMab Q2W | -40.44 |
| A10 EvoMab QM | -42.45 |
| A80 PBO Q2W | 4.26 |
| A80 PBO QM | 6.42 |
| A80 EZE (Q2W) | -11.92 |
| A80 EZE (QM) | -12.25 |
| A80 EvoMab Q2W | -40.22 |
| A80 EvoMab QM | -40.43 |
| R5 PBO Q2W | 5.41 |
| R5 PBO QM | 5.02 |
| R5 EvoMab Q2W | -39.33 |
| R5 EvoMab QM | -42.00 |
| R40 PBO Q2W | 4.55 |
| R40 PBO QM | 1.71 |
| R40 EvoMab Q2W | -36.04 |
| R40 EvoMab QM | -38.62 |
| S40 PBO Q2W | -0.14 |
| S40 PBO QM | 5.45 |
| S40 EvoMab Q2W | -47.20 |
| S40 EvoMab QM | -43.17 |
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.80 |
| A10 PBO QM | 1.28 |
| A10 EZE (Q2W) | -20.71 |
| A10 EZE (QM) | -16.56 |
| A10 EvoMab Q2W | -53.48 |
| A10 EvoMab QM | -56.09 |
| A80 PBO Q2W | 10.74 |
| A80 PBO QM | 8.45 |
| A80 EZE (Q2W) | -16.19 |
| A80 EZE (QM) | -18.79 |
| A80 EvoMab Q2W | -54.44 |
| A80 EvoMab QM | -56.31 |
| R5 PBO Q2W | 7.02 |
| R5 PBO QM | 3.73 |
| R5 EvoMab Q2W | -52.59 |
| R5 EvoMab QM | -55.47 |
| R40 PBO Q2W | 6.19 |
| R40 PBO QM | 1.58 |
| R40 EvoMab Q2W | -52.08 |
| R40 EvoMab QM | -55.72 |
| S40 PBO Q2W | 0.74 |
| S40 PBO QM | 6.81 |
| S40 EvoMab Q2W | -59.33 |
| S40 EvoMab QM | -56.01 |
Percent Change From Baseline in Non-HDL-C at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 8.25 |
| A10 PBO QM | 2.43 |
| A10 EZE (Q2W) | -18.27 |
| A10 EZE (QM) | -14.78 |
| A10 EvoMab Q2W | -53.39 |
| A10 EvoMab QM | -52.20 |
| A80 PBO Q2W | 11.79 |
| A80 PBO QM | 9.95 |
| A80 EZE (Q2W) | -14.34 |
| A80 EZE (QM) | -17.26 |
| A80 EvoMab Q2W | -54.84 |
| A80 EvoMab QM | -50.05 |
| R5 PBO Q2W | 7.92 |
| R5 PBO QM | 5.85 |
| R5 EvoMab Q2W | -52.04 |
| R5 EvoMab QM | -51.57 |
| R40 PBO Q2W | 8.61 |
| R40 PBO QM | 3.35 |
| R40 EvoMab Q2W | -50.97 |
| R40 EvoMab QM | -46.42 |
| S40 PBO Q2W | 1.89 |
| S40 PBO QM | 5.66 |
| S40 EvoMab Q2W | -59.02 |
| S40 EvoMab QM | -50.96 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 9.86 |
| A10 PBO QM | 0.97 |
| A10 EZE (Q2W) | -21.96 |
| A10 EZE (QM) | -17.08 |
| A10 EvoMab Q2W | -61.56 |
| A10 EvoMab QM | -58.19 |
| A80 PBO Q2W | 14.49 |
| A80 PBO QM | 11.83 |
| A80 EZE (Q2W) | -14.60 |
| A80 EZE (QM) | -19.80 |
| A80 EvoMab Q2W | -61.80 |
| A80 EvoMab QM | -58.68 |
| R5 PBO Q2W | 8.12 |
| R5 PBO QM | 5.10 |
| R5 EvoMab Q2W | -60.09 |
| R5 EvoMab QM | -59.40 |
| R40 PBO Q2W | 9.42 |
| R40 PBO QM | 2.59 |
| R40 EvoMab Q2W | -58.89 |
| R40 EvoMab QM | -52.40 |
| S40 PBO Q2W | 4.70 |
| S40 PBO QM | 3.40 |
| S40 EvoMab Q2W | -65.86 |
| S40 EvoMab QM | -57.02 |
Percent Change From Baseline in Lipoprotein(a) at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 7.34 |
| A10 PBO QM | -0.43 |
| A10 EZE (Q2W) | 3.29 |
| A10 EZE (QM) | 7.18 |
| A10 EvoMab Q2W | -25.87 |
| A10 EvoMab QM | -20.25 |
| A80 PBO Q2W | -2.23 |
| A80 PBO QM | 3.41 |
| A80 EZE (Q2W) | 8.01 |
| A80 EZE (QM) | 10.20 |
| A80 EvoMab Q2W | -24.61 |
| A80 EvoMab QM | -24.68 |
| R5 PBO Q2W | 11.40 |
| R5 PBO QM | 4.49 |
| R5 EvoMab Q2W | -25.09 |
| R5 EvoMab QM | -20.85 |
| R40 PBO Q2W | 10.38 |
| R40 PBO QM | 10.21 |
| R40 EvoMab Q2W | -26.11 |
| R40 EvoMab QM | -21.97 |
| S40 PBO Q2W | -6.81 |
| S40 PBO QM | -1.06 |
| S40 EvoMab Q2W | -38.06 |
| S40 EvoMab QM | -29.23 |
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.07 |
| A10 PBO QM | -0.77 |
| A10 EZE (Q2W) | 1.44 |
| A10 EZE (QM) | 6.85 |
| A10 EvoMab Q2W | -26.01 |
| A10 EvoMab QM | -22.64 |
| A80 PBO Q2W | -3.45 |
| A80 PBO QM | 1.51 |
| A80 EZE (Q2W) | 8.05 |
| A80 EZE (QM) | 9.96 |
| A80 EvoMab Q2W | -23.97 |
| A80 EvoMab QM | -27.46 |
| R5 PBO Q2W | 11.41 |
| R5 PBO QM | 3.65 |
| R5 EvoMab Q2W | -24.26 |
| R5 EvoMab QM | -23.16 |
| R40 PBO Q2W | 8.59 |
| R40 PBO QM | 6.26 |
| R40 EvoMab Q2W | -24.96 |
| R40 EvoMab QM | -25.93 |
| S40 PBO Q2W | -10.57 |
| S40 PBO QM | -4.99 |
| S40 EvoMab Q2W | -38.64 |
| S40 EvoMab QM | -32.16 |
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 8.54 |
| A10 PBO QM | 0.35 |
| A10 EZE (Q2W) | -23.88 |
| A10 EZE (QM) | -18.98 |
| A10 EvoMab Q2W | -61.41 |
| A10 EvoMab QM | -62.47 |
| A80 PBO Q2W | 13.12 |
| A80 PBO QM | 9.76 |
| A80 EZE (Q2W) | -16.85 |
| A80 EZE (QM) | -21.25 |
| A80 EvoMab Q2W | -61.80 |
| A80 EvoMab QM | -65.05 |
| R5 PBO Q2W | 7.55 |
| R5 PBO QM | 2.79 |
| R5 EvoMab Q2W | -59.33 |
| R5 EvoMab QM | -63.79 |
| R40 PBO Q2W | 6.57 |
| R40 PBO QM | -0.02 |
| R40 EvoMab Q2W | -59.08 |
| R40 EvoMab QM | -62.94 |
| S40 PBO Q2W | 3.26 |
| S40 PBO QM | 6.00 |
| S40 EvoMab Q2W | -66.17 |
| S40 EvoMab QM | -62.45 |
Percent Change From Baseline in HDL-C at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 0.22 |
| A10 PBO QM | 0.01 |
| A10 EZE (Q2W) | -1.76 |
| A10 EZE (QM) | -0.40 |
| A10 EvoMab Q2W | 7.04 |
| A10 EvoMab QM | 7.88 |
| A80 PBO Q2W | 5.02 |
| A80 PBO QM | 0.30 |
| A80 EZE (Q2W) | 0.62 |
| A80 EZE (QM) | 0.21 |
| A80 EvoMab Q2W | 9.09 |
| A80 EvoMab QM | 7.36 |
| R5 PBO Q2W | 2.87 |
| R5 PBO QM | -0.16 |
| R5 EvoMab Q2W | 6.07 |
| R5 EvoMab QM | 7.18 |
| R40 PBO Q2W | -0.39 |
| R40 PBO QM | 0.73 |
| R40 EvoMab Q2W | 4.65 |
| R40 EvoMab QM | 5.57 |
| S40 PBO Q2W | 1.14 |
| S40 PBO QM | -2.65 |
| S40 EvoMab Q2W | 10.92 |
| S40 EvoMab QM | 6.41 |
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | -0.99 |
| A10 PBO QM | -0.45 |
| A10 EZE (Q2W) | -1.13 |
| A10 EZE (QM) | -0.92 |
| A10 EvoMab Q2W | 5.54 |
| A10 EvoMab QM | 7.66 |
| A80 PBO Q2W | 4.48 |
| A80 PBO QM | -1.37 |
| A80 EZE (Q2W) | 0.86 |
| A80 EZE (QM) | -0.59 |
| A80 EvoMab Q2W | 8.44 |
| A80 EvoMab QM | 7.76 |
| R5 PBO Q2W | 0.87 |
| R5 PBO QM | -0.94 |
| R5 EvoMab Q2W | 6.23 |
| R5 EvoMab QM | 7.72 |
| R40 PBO Q2W | -0.60 |
| R40 PBO QM | -0.40 |
| R40 EvoMab Q2W | 4.86 |
| R40 EvoMab QM | 6.35 |
| S40 PBO Q2W | 0.13 |
| S40 PBO QM | -2.14 |
| S40 EvoMab Q2W | 10.35 |
| S40 EvoMab QM | 6.71 |
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.13 |
| A10 PBO QM | -1.21 |
| A10 EZE (Q2W) | -14.51 |
| A10 EZE (QM) | -12.33 |
| A10 EvoMab Q2W | -54.17 |
| A10 EvoMab QM | -49.65 |
| A80 PBO Q2W | 4.19 |
| A80 PBO QM | 6.50 |
| A80 EZE (Q2W) | -13.69 |
| A80 EZE (QM) | -12.19 |
| A80 EvoMab Q2W | -53.59 |
| A80 EvoMab QM | -50.76 |
| R5 PBO Q2W | 1.44 |
| R5 PBO QM | 4.00 |
| R5 EvoMab Q2W | -52.97 |
| R5 EvoMab QM | -52.13 |
| R40 PBO Q2W | 1.64 |
| R40 PBO QM | 3.16 |
| R40 EvoMab Q2W | -47.53 |
| R40 EvoMab QM | -45.65 |
| S40 PBO Q2W | -1.80 |
| S40 PBO QM | -0.52 |
| S40 EvoMab Q2W | -59.53 |
| S40 EvoMab QM | -52.56 |
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.41 |
| A10 PBO QM | 0.78 |
| A10 EZE (Q2W) | -15.77 |
| A10 EZE (QM) | -11.47 |
| A10 EvoMab Q2W | -53.56 |
| A10 EvoMab QM | -53.33 |
| A80 PBO Q2W | 4.48 |
| A80 PBO QM | 5.79 |
| A80 EZE (Q2W) | -15.17 |
| A80 EZE (QM) | -12.91 |
| A80 EvoMab Q2W | -52.43 |
| A80 EvoMab QM | -56.20 |
| R5 PBO Q2W | 2.82 |
| R5 PBO QM | 2.58 |
| R5 EvoMab Q2W | -52.46 |
| R5 EvoMab QM | -56.66 |
| R40 PBO Q2W | 2.17 |
| R40 PBO QM | 2.60 |
| R40 EvoMab Q2W | -48.47 |
| R40 EvoMab QM | -54.17 |
| S40 PBO Q2W | -1.00 |
| S40 PBO QM | -1.42 |
| S40 EvoMab Q2W | -58.76 |
| S40 EvoMab QM | -57.47 |
Percent Change From Baseline in Apolipoprotein B at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 7.89 |
| A10 PBO QM | 0.21 |
| A10 EZE (Q2W) | -15.98 |
| A10 EZE (QM) | -10.95 |
| A10 EvoMab Q2W | -50.90 |
| A10 EvoMab QM | -47.15 |
| A80 PBO Q2W | 11.64 |
| A80 PBO QM | 6.54 |
| A80 EZE (Q2W) | -12.31 |
| A80 EZE (QM) | -12.16 |
| A80 EvoMab Q2W | -49.77 |
| A80 EvoMab QM | -46.47 |
| R5 PBO Q2W | 6.35 |
| R5 PBO QM | 4.63 |
| R5 EvoMab Q2W | -50.15 |
| R5 EvoMab QM | -48.58 |
| R40 PBO Q2W | 4.91 |
| R40 PBO QM | 3.24 |
| R40 EvoMab Q2W | -45.61 |
| R40 EvoMab QM | -43.71 |
| S40 PBO Q2W | 0.35 |
| S40 PBO QM | 3.57 |
| S40 EvoMab Q2W | -55.95 |
| S40 EvoMab QM | -49.16 |
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | percent change (Least Squares Mean) |
|---|
| A10 PBO Q2W | 7.55 |
| A10 PBO QM | 0.81 |
| A10 EZE (Q2W) | -17.29 |
| A10 EZE (QM) | -11.43 |
| A10 EvoMab Q2W | -50.95 |
| A10 EvoMab QM | -51.44 |
| A80 PBO Q2W | 10.20 |
| A80 PBO QM | 5.48 |
| A80 EZE (Q2W) | -14.22 |
| A80 EZE (QM) | -13.62 |
| A80 EvoMab Q2W | -49.14 |
| A80 EvoMab QM | -53.26 |
| R5 PBO Q2W | 5.07 |
| R5 PBO QM | 2.54 |
| R5 EvoMab Q2W | -49.79 |
| R5 EvoMab QM | -53.59 |
| R40 PBO Q2W | 3.71 |
| R40 PBO QM | 1.98 |
| R40 EvoMab Q2W | -47.07 |
| R40 EvoMab QM | -52.95 |
| S40 PBO Q2W | -0.31 |
| S40 PBO QM | 2.49 |
| S40 EvoMab Q2W | -55.65 |
| S40 EvoMab QM | -54.37 |
Change From Baseline in LDL-C at Week 12
(NCT01763866)
Timeframe: Baseline and Week 12
| Intervention | mg/dL (Least Squares Mean) |
|---|
| A10 PBO Q2W | 8.6 |
| A10 PBO QM | 0.8 |
| A10 EZE (Q2W) | -30.1 |
| A10 EZE (QM) | -23.3 |
| A10 EvoMab Q2W | -77.0 |
| A10 EvoMab QM | -75.1 |
| A80 PBO Q2W | 12.7 |
| A80 PBO QM | 7.0 |
| A80 EZE (Q2W) | -9.9 |
| A80 EZE (QM) | -19.5 |
| A80 EvoMab Q2W | -59.0 |
| A80 EvoMab QM | -54.8 |
| R5 PBO Q2W | 7.8 |
| R5 PBO QM | 2.4 |
| R5 EvoMab Q2W | -69.2 |
| R5 EvoMab QM | -73.3 |
| R40 PBO Q2W | 5.1 |
| R40 PBO QM | -2.0 |
| R40 EvoMab Q2W | -52.1 |
| R40 EvoMab QM | -46.7 |
| S40 PBO Q2W | -4.5 |
| S40 PBO QM | -0.6 |
| S40 EvoMab Q2W | -83.5 |
| S40 EvoMab QM | -72.5 |
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
(NCT01763866)
Timeframe: Baseline and Weeks 10 and 12
| Intervention | mg/dL (Least Squares Mean) |
|---|
| A10 PBO Q2W | 6.8 |
| A10 PBO QM | -0.4 |
| A10 EZE (Q2W) | -32.4 |
| A10 EZE (QM) | -25.1 |
| A10 EvoMab Q2W | -76.8 |
| A10 EvoMab QM | -80.1 |
| A80 PBO Q2W | 11.0 |
| A80 PBO QM | 5.5 |
| A80 EZE (Q2W) | -13.0 |
| A80 EZE (QM) | -21.3 |
| A80 EvoMab Q2W | -58.8 |
| A80 EvoMab QM | -60.1 |
| R5 PBO Q2W | 6.5 |
| R5 PBO QM | 0.1 |
| R5 EvoMab Q2W | -68.9 |
| R5 EvoMab QM | -77.8 |
| R40 PBO Q2W | 3.4 |
| R40 PBO QM | -4.8 |
| R40 EvoMab Q2W | -52.3 |
| R40 EvoMab QM | -55.3 |
| S40 PBO Q2W | -5.7 |
| S40 PBO QM | 1.7 |
| S40 EvoMab Q2W | -83.8 |
| S40 EvoMab QM | -78.4 |
Cmax,ss of Faldaprevir (Statins Part)
Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
| Intervention | ng/mL (Geometric Mean) |
|---|
| Atorvastatin+Faldaprevir | 12900 |
| Rosuvastatin+Faldaprevir | 12200 |
Cmax,ss (Itraconazole Part)
"Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.
| Intervention | ng/mL (Geometric Mean) |
|---|
| Faldaprevir | 2780 |
| Faldaprevir+Itraconazole | 5030 |
Cmax of Rosuvastatin
"Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
| Intervention | ng/mL (Geometric Mean) |
|---|
| Rosuvastatin | 2.73 |
| Rosuvastatin+Faldaprevir | 89.6 |
Cmax of Atorvastatin (Statins Part)
"Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
| Intervention | ng/mL (Geometric Mean) |
|---|
| Atorvastatin | 0.94 |
| Atorvastatin+Faldaprevir | 31.10 |
AUCÏ„,ss of Faldaprevir (Statins Part)
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Atorvastatin+Faldaprevir | 145000 |
| Rosuvastatin+Faldaprevir | 136000 |
AUCÏ„,ss (Itraconazole Part)
Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Faldaprevir | 29900 |
| Faldaprevir+Itraconazole | 59500 |
AUC0-tz of Rosuvastatin
"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Rosuvastatin | 21.5 |
| Rosuvastatin+Faldaprevir | 361.0 |
AUC0-tz of Atorvastatin
"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Atorvastatin | 9.5 |
| Atorvastatin+Faldaprevir | 129.6 |
AUC0-∞ of Rosuvastatin (Statins Part)
"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Rosuvastatin | 24.9 |
| Rosuvastatin+Faldaprevir | 365.0 |
AUC0-∞ of Atorvastatin (Statins Part)
"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities." (NCT01795937)
Timeframe: -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Atorvastatin | 13.7 |
| Atorvastatin+Faldaprevir | 129.0 |
Rates of Adverse Events
Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication (NCT01813357)
Timeframe: Will be assessed every 12 weeks and formally reported at 96 weeks of followup
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 22 |
| Rosuvastatin | 35 |
Mechanism of Reverse Cholesterol Transport
To assess the mechanism of reverse cholesterol transport that arises with high-dose statin therapy, as related to changes in plaque lipid content and morphology, and systemic vascular inflammation. Reverse cholesterol transport (RCT) is a pathway by which accumulated cholesterol is transported from the vessel wall to the liver for excretion, thus preventing atherosclerosis. (NCT01837823)
Timeframe: baseline and at 8-12 weeks
| Intervention | percentage of cholesterol (Mean) |
|---|
| Baseline | 0.81 |
| 8-12 Weeks | 0.84 |
MACE
Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 1 year. (NCT01837823)
Timeframe: at 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Rosuvastatin | 33 |
Lesion LCBI
As related to other outcomes, change in LCBI measured across the entire lesion (rather than ΔLCBI4mm max). The LCBI Score, computed as the fraction of valid pixels within the scanned region that exceeded a LCP probability of 0.6 multiplied by 1000, summarized the amount of LCP in the entire scanned region of the coronary vessel on a 0-to-1000 scale . (NCT01837823)
Timeframe: at baseline and at 8-12 weeks
| Intervention | LCBI4mm max (Median) |
|---|
| Baseline | 142.84 |
| 8-12 Weeks | 141.93 |
LCBI 4mm at Same Anatomical Site
"As related to other outcomes, change in LCBI 4mm measured at the identical anatomical site at both time points, as defined by the LCBI4mm max site at baseline (rather than ΔLCBI4mm max).~LCBI4mm: 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow." (NCT01837823)
Timeframe: at baseline and at 8-12 weeks
| Intervention | LCBI4mm max (Mean) |
|---|
| Baseline | 416.6 |
| 8-12 Weeks | 383.2 |
Fibrous Cap Thickness (FCT) by OCT
ΔFibrous Cap Thickness measured by OCT at baseline and at 8-12 weeks (NCT01837823)
Timeframe: baseline and at 8-12 weeks
| Intervention | μm (Mean) |
|---|
| Baseline | 100.9 |
| 8-12 Weeks | 108.6 |
Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max
Correlation of baseline lipid parameters with baseline LCBI4mm max (NCT01837823)
Timeframe: baseline
| Intervention | Beta coefficient (Number) |
|---|
| Rosuvastatin | 0.07 |
Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP
Correlation between the change in plaque morphology composition by intravascular imaging with inflammatory cell activity. (NCT01837823)
Timeframe: baseline and 8-12 weeks
| Intervention | beta coefficient (Number) |
|---|
| Rosuvastatin | -0.27 |
Correlation Between Plaque Morphology and HDL Functionality
Correlation between the changes in plaque morphology composition by intravascular imaging with changes in HDL functionality. HDL functionality is measured by the Cholesterol Efflux Capacity (CEC). Plaque morphology is represented by the Fibrous Cap Thickness. (NCT01837823)
Timeframe: baseline and 8-12 weeks
| Intervention | beta coefficient (Number) |
|---|
| Rosuvastatin | 0.30 |
Change in Atheroma Volume
Change in total atheroma volume (TAV) and lumen cross sectional area on OCT. (NCT01837823)
Timeframe: baseline and at 8-12 weeks
| Intervention | mm^3 (Mean) |
|---|
| Baseline | 182.3 |
| 8-12 Weeks | 182.7 |
MACE
Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days. (NCT01837823)
Timeframe: at 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Myocardial infarction | Revascularization | Stroke |
|---|
| Rosuvastatin | 1 | 2 | 0 |
IVUS Imaging Measures
Correlation between ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in specific IVUS (ΔPlaque burden) imaging measures. Plaque burden is Plaque + Media divided by Total Plaque Area in %. (NCT01837823)
Timeframe: Baseline and 8 weeks
| Intervention | percent of plaque burden (Mean) |
|---|
| Reference Site | Minimum Lumen Area Site |
|---|
| 8-12 Weeks | 38.93 | 75.79 |
,| Baseline | 38.75 | 75.93 |
Inflammatory and Lipid Parameters
ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in inflammatory and lipid parameters responses to patient-derived samples. (NCT01837823)
Timeframe: baseline and at 8-12 weeks
| Intervention | mg/dl (Mean) |
|---|
| Total Cholesterol | LDL Cholesterol | HDL Cholesterol | Triglyceride | ApoB | Apo-AI | hs-CRP |
|---|
| 8-12 Weeks | 115.0 | 50.6 | 42.2 | 107.8 | 57.4 | 126.9 | 27.0 |
,| Baseline | 153.3 | 86.8 | 41.2 | 128.6 | 79.6 | 120.1 | 35.0 |
Biomarker Release
Post procedure CK-MB, Troponin-I release at final YELLOW lesion PCI. (NCT01837823)
Timeframe: within 24 hrs of PCI
| Intervention | ng/ml (Mean) |
|---|
| CK-MB | Troponin-I |
|---|
| Rosuvastatin | 30. | 0.35 |
Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max)
"Maximum LCBI 4mm (ΔLCBI4mm max) of the non-culprit YELLOW lesion at baseline and 8-12 weeks thereafter.~LCBI4mm max : 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow." (NCT01837823)
Timeframe: baseline and at 8-12 weeks
| Intervention | LCBI4mm max (Mean) |
|---|
| Baseline | 416.6 |
| 8-12 Weeks | 400.2 |
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| LDL-C | TG | TC | HDL-C | Non-HDL-C |
|---|
| 100 mg LY3015014 Q8W | -18.4 | -7.2 | -11.0 | 4.5 | -16.1 |
,| 120 mg LY3015014 Q4W | -46.4 | -7.2 | -27.8 | 7.3 | -39.3 |
,| 20 mg LY3015014 Q4W | -18.0 | -6.1 | -10.5 | 4.5 | -16.1 |
,| 300 mg LY3015014 Q4W | -56.5 | -15.1 | -34.1 | 8.8 | -48.9 |
,| 300 mg LY3015014 Q8W | -42.2 | -10.6 | -24.6 | 8.4 | -35.8 |
,| Placebo Q4W | 5.9 | 3.5 | 3.5 | 1.6 | 4.9 |
Number of Participants With an Injection Site Reaction
(NCT01890967)
Timeframe: Baseline through Week 24
| Intervention | Participants (Number) |
|---|
| Placebo Q4W | 26 |
| 20 mg LY3015014 Q4W | 42 |
| 120 mg LY3015014 Q4W | 57 |
| 300 mg LY3015014 Q4W | 51 |
| 100 mg LY3015014 Q8W | 36 |
| 300 mg LY3015014 Q8W | 41 |
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Placebo Q4W | 0.5 |
| 20 mg LY3015014 Q4W | -0.2 |
| 120 mg LY3015014 Q4W | 1.6 |
| 300 mg LY3015014 Q4W | -0.3 |
| 100 mg LY3015014 Q8W | -0.3 |
| 300 mg LY3015014 Q8W | -0.7 |
Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
(NCT01890967)
Timeframe: Baseline through Week 24
| Intervention | Participants (Number) |
|---|
| Placebo Q4W | 4 |
| 20 mg LY3015014 Q4W | 6 |
| 120 mg LY3015014 Q4W | 10 |
| 300 mg LY3015014 Q4W | 5 |
| 100 mg LY3015014 Q8W | 4 |
| 300 mg LY3015014 Q8W | 3 |
Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Placebo Q4W | 9.9 |
| 20 mg LY3015014 Q4W | -16.3 |
| 120 mg LY3015014 Q4W | -36.6 |
| 300 mg LY3015014 Q4W | -68.0 |
| 100 mg LY3015014 Q8W | -4.4 |
| 300 mg LY3015014 Q8W | -35.2 |
Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage Change (Least Squares Mean) |
|---|
| Placebo Q4W | -0.31 |
| 20 mg LY3015014 Q4W | -16.63 |
| 120 mg LY3015014 Q4W | -19.02 |
| 300 mg LY3015014 Q4W | -37.29 |
| 100 mg LY3015014 Q8W | -7.54 |
| 300 mg LY3015014 Q8W | -21.01 |
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Placebo Q4W | 7.6 |
| 20 mg LY3015014 Q4W | -14.9 |
| 120 mg LY3015014 Q4W | -40.5 |
| 300 mg LY3015014 Q4W | -50.5 |
| 100 mg LY3015014 Q8W | -14.9 |
| 300 mg LY3015014 Q8W | -37.1 |
Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Placebo Q4W | 14.6 |
| 20 mg LY3015014 Q4W | 9.1 |
| 120 mg LY3015014 Q4W | 86.4 |
| 300 mg LY3015014 Q4W | 130.6 |
| 100 mg LY3015014 Q8W | 21.8 |
| 300 mg LY3015014 Q8W | 41.0 |
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014
(NCT01890967)
Timeframe: Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose
| Intervention | μg∙hr/mL (Geometric Mean) |
|---|
| 20 mg LY3015014 Q4W | 1590 |
| 120 mg LY3015014 Q4W | 9670 |
| 300 mg LY3015014 Q4W | 27300 |
| 100 mg LY3015014 Q8W | 7800 |
| 300 mg LY3015014 Q8W | 26600 |
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable. (NCT01890967)
Timeframe: Baseline, Week 16
| Intervention | Percentage change (Least Squares Mean) |
|---|
| Apo A1 | Apo B |
|---|
| 100 mg LY3015014 Q8W | 3.8 | -16.0 |
,| 120 mg LY3015014 Q4W | 6.5 | -34.9 |
,| 20 mg LY3015014 Q4W | 2.4 | -16.6 |
,| 300 mg LY3015014 Q4W | 6.2 | -46.8 |
,| 300 mg LY3015014 Q8W | 5.8 | -31.9 |
,| Placebo Q4W | 0.3 | 4.2 |
sitDBP Changes at Week 8 From Baseline
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline (NCT01918332)
Timeframe: 8 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|
| V160+R20 & V160 | -9.24 |
| R20 & Placebo | -2.9 |
LDL-C Percentage Changes at Week 8 From Baseline
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline (NCT01918332)
Timeframe: 8 weeks
| Intervention | percent change (Least Squares Mean) |
|---|
| V160+R20 & R20 | -49.91 |
| V160 & Placebo | -2.38 |
Plaque Volume of Carotid Arteries
Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events. (NCT02114697)
Timeframe: Baseline, 18 months, 36 months
| Intervention | Cubic millimeter (mm^3) (Mean) |
|---|
| Baseline | Month 18 |
|---|
| Statin Therapy | 108.88 | 114.70 |
Plaque Volume of Carotid Arteries
Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events. (NCT02114697)
Timeframe: Baseline, 18 months, 36 months
| Intervention | Cubic millimeter (mm^3) (Mean) |
|---|
| Baseline |
|---|
| Lifestyle Modification | 125.18 |
TC (mg/dL)
Efficacy in terms of total cholesterol (TC) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 447.6 |
| C-FAS Placebo | 539.0 |
Non-HDL C/HDL C
Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | ratio (Mean) |
|---|
| C-FAS Rosuvastatin | 12.704 |
| C-FAS Placebo | 16.416 |
Non-HDL C (mmol/L)
Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 10.67 |
| C-FAS Placebo | 13.09 |
Non-HDL C (mg/dL)
Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 412.1 |
| C-FAS Placebo | 505.3 |
HDL-C (mmol/L)
Efficacy in terms of high density lipoprotein cholesterol (HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 0.92 |
| C-FAS Placebo | 0.87 |
Weight
Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight. (NCT02226198)
Timeframe: Week 0 (start of cross-over), weeks 6, week 12 and week 18
| Intervention | kg (Mean) |
|---|
| Weight (kg) week 0 | Weight (kg) week 6 | Weight (kg) week 12 | Weight (kg) week 18 | Weight (kg) week 24 |
|---|
| Pla/Ros | 40.19 | 40.36 | 42.30 | 42.50 | 43.00 |
,| Ros/Pla | 37.39 | 38.14 | 38.63 | 39.31 | 39.90 |
Urinalysis Abnormalitites
Safety and tolerability will be described in terms of abnormal urine laboratory values (NCT02226198)
Timeframe: Week 0, week 6, week 12 and week 18
| Intervention | participants (Number) |
|---|
| Urine Protein week 0 | Urine Protein week 6 | Urine Protein week 12 | Urine Protein week 18 | Urine Protein week 24 | Urine Ketones week 0 | Urine Ketones week 6 | Urine Ketones week 12 | Urine Ketones week 18 | Urine Ketones week 24 | Urine Blood week 0 | Urine Blood week 6 | Urine Blood week 12 | Urine Blood week 18 | Urine Blood week 24 |
|---|
| Pla/Ros | 2 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 2 | 1 | 1 |
,| Ros/Pla | 3 | 1 | 3 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 1 |
Tanner Stage
"Stages for fem (Pubic hair, Breasts):~(Preadol,Preadol)~(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)~(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)~(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)~(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)~1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred." (NCT02226198)
Timeframe: Week 0 (start of cross-over)
| Intervention | stage (Mean) |
|---|
| Tanner stage week 0 | Tanner stage week 24 |
|---|
| Pla/Ros | 1.7 | 2.0 |
,| Ros/Pla | 2.0 | 2.3 |
Physical Exam Abnormalitites
Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported. (NCT02226198)
Timeframe: Screening, Week 0, week 6, week 12 and week 18, week 24
| Intervention | participants (Number) |
|---|
| General Appearance screening | General Appearance week 0 | General Appearance week 6 | General Appearance week 12 | General Appearance week 18 | General Appearance week 24 | Head and Neck screening | Head and Neck week 0 | Head and Neck week 6 | Head and Neck week 12 | Head and Neck week 18 | Head and Neck week 24 | Lymph Nodes screening | Lymph Nodes week 0 | Lymph Nodes week 6 | Lymph Nodes week 12 | Lymph Nodes week 18 | Lymph Nodes week 24 | Skin screening | Skin week 0 | Skin week 6 | Skin week 12 | Skin week 18 | Skin week 24 |
|---|
| Pla/Ros | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 2 | 2 |
,| Ros/Pla | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 | 5 | 5 | 5 | 5 |
TG (mmol/L)
Efficacy in terms of triglycerides (TG) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 0.90 |
| C-FAS Placebo | 1.35 |
LDL-Cholesterol (mmol/L)
Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment (NCT02226198)
Timeframe: Samples taken on Day 42 (week 6) and on day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 10.26 |
| C-FAS Placebo | 12.47 |
LDL-Cholesterol (mg/dL)
Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment (NCT02226198)
Timeframe: Samples taken on Day 42 (week 6) and on day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 396.0 |
| C-FAS Placebo | 481.4 |
LDL-C, Not on Apheresis (mmol/L)
Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 12.43 |
| C-FAS Placebo Not on Apheresis | 15.40 |
LDL-C, Not on Apheresis (mg/dL)
Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 479.8 |
| C-FAS Placebo | 594.7 |
Abnormal Vital Signs
Safety and tolerability will be described in terms of abnormal vital signs (NCT02226198)
Timeframe: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
| Intervention | participants (Number) |
|---|
| Safety Analysis Set | 0 |
AE's Leading to Discontinuation
Safety and tolerability will be described in terms of rate of discontinuations due to adverse events (NCT02226198)
Timeframe: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
| Intervention | adverse events (Number) |
|---|
| Lead-in | 0 |
| Cross-over Phase | 0 |
| Maintenance Phase | 0 |
ApoB (g/L)
Efficacy in terms of apolipoprotein B (ApoB) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | g/L (Mean) |
|---|
| C-FAS Rosuvastatin | 2.35 |
| C-FAS Placebo | 2.68 |
ApoB (mg/dL)
Efficacy in terms of apolipoprotein B (ApoB) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 234.9 |
| C-FAS Placebo | 267.9 |
ApoB/ApoA
Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | ratio (Mean) |
|---|
| C-FAS Rosuvastatin | 2.408 |
| C-FAS Placebo | 2.873 |
ECG Abnormalities
Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG) (NCT02226198)
Timeframe: Week 0
| Intervention | participants (Number) |
|---|
| Safety Analysis Set | 0 |
| C-FAS Rosuvastatin | 0 |
| C-FAS Placebo | 0 |
LDL C/HDL C
Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | ratio (Mean) |
|---|
| C-FAS Rosuvastatin | 12.208 |
| C-FAS Placebo | 15.600 |
HDL-C (mg/dL)
Efficacy in terms of high density lipoprotein cholesterol (HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 35.5 |
| C-FAS Placebo | 33.7 |
LDL-C From End of Placebo (mmol/L)
Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)
| Intervention | mmol/L (Mean) |
|---|
| End of Placebo | 6 weeks after end of Placebo | 12 weeks after end of Placebo | 18 weeks after end of Placebo |
|---|
| M-FAS Placebo | 12.73 | 10.92 | 10.22 | 11.44 |
,| M-FAS Rosuvastatin | 12.25 | 10.34 | 8.96 | NA |
LDL-C From End of Placebo (mg/dL)
Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)
| Intervention | mg/dL (Mean) |
|---|
| End of Placebo | 6 weeks after end of Placebo | 12 weeks after end of Placebo | 18 weeks after end of Placebo |
|---|
| M-FAS Placebo | 491.3 | 421.7 | 394.7 | 441.8 |
,| M-FAS Rosuvastatin | 472.9 | 399.4 | 345.8 | NA |
Height Z-score
Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight. (NCT02226198)
Timeframe: Week 0 (start of cross-over), weeks 6, week 12 and week 18
| Intervention | ratio (Mean) |
|---|
| Height z-score week 0 | Height z-score week 6 | Height z-score week 12 | Height z-score week 18 | Height z-score week 24 |
|---|
| Pla/Ros | -0.75 | -0.71 | -0.70 | -0.65 | -0.49 |
,| Ros/Pla | -0.42 | -0.29 | -0.18 | 0.00 | 0.04 |
Height
Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight. (NCT02226198)
Timeframe: Week 0 (start of cross-over), weeks 6, week 12 and week 18
| Intervention | cm (Mean) |
|---|
| Height (cm) week 0 | Height (cm) week 6 | Height (cm) week 12 | Height (cm) week 18 | Height (cm) week 24 |
|---|
| Pla/Ros | 140.9 | 141.1 | 142.0 | 142.3 | 143.5 |
,| Ros/Pla | 144.0 | 144.9 | 145.7 | 146.9 | 147.1 |
Adverse Events
Safety and tolerability will be described in terms of frequency and severity of adverse events (NCT02226198)
Timeframe: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
| Intervention | adverse events (Number) |
|---|
| Any AE | Any TEAE | Any AE leading to death | Any SAE |
|---|
| Cross-over Phase | 5 | 5 | 0 | 0 |
,| Lead-in | 4 | 4 | 0 | 0 |
,| Maintenance | 1 | 1 | 0 | 0 |
Abnormal Serum Levels
Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found (NCT02226198)
Timeframe: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
| Intervention | participants (Number) |
|---|
| Alanine Aminotransferase week 0 | Alanine Aminotransferase week 6 | Alanine Aminotransferase week 12 | Alanine Aminotransferase week 18 | Alanine Aminotransferase week 24 | Albumin week 0 | Albumin week 6 | Albumin week 12 | Albumin week 18 | Albumin week 24 | Bicarbonate week 0 | Bicarbonate week 6 | Bicarbonate week 12 | Bicarbonate week 18 | Bicarbonate week 24 | Blood Urea Nitrogen week 0 | Blood Urea Nitrogen week 6 | Blood Urea Nitrogen week 12 | Blood Urea Nitrogen week 18 | Blood Urea Nitrogen week 24 | Chloride week 0 | Chloride week 6 | Chloride week 12 | Chloride week 18 | Chloride week 24 | Creatine Kinase week 0 | Creatine Kinase week 6 | Creatine Kinase week 12 | Creatine Kinase week 18 | Creatine Kinase week 24 | Glucose week 0 | Glucose week 6 | Glucose week 12 | Glucose week 18 | Glucose week 24 | Potassium week 0 | Potassium week 6 | Potassium week 12 | Potassium week 18 | Potassium week 24 | Protein week 0 | Protein week 6 | Protein week 12 | Protein week 18 | Protein week 24 | Sodium week 0 | Sodium week 6 | Sodium week 12 | Sodium week 18 | Sodium week 24 | Total Bilirubin week 0 | Total Bilirubin week 6 | Total Bilirubin week 12 | Total Bilirubin week 18 | Total Bilirubin week 24 | Urate week 0 | Urate week 6 | Urate week 12 | Urate week 18 | Urate week 24 | Ery. Mean Corpuscular HGB Concentration week 0 | Ery. Mean Corpuscular HGB Concentration week 6 | Ery. Mean Corpuscular HGB Concentration week 12 | Ery. Mean Corpuscular HGB Concentration week 18 | Ery. Mean Corpuscular HGB Concentration week 24 | Ery. Mean Corpuscular Hemoglobin week 0 | Ery. Mean Corpuscular Hemoglobin week 6 | Ery. Mean Corpuscular Hemoglobin week 12 | Ery. Mean Corpuscular Hemoglobin week 18 | Ery. Mean Corpuscular Hemoglobin week 24 | Ery. Mean Corpuscular Volume week 0 | Ery. Mean Corpuscular Volume week 6 | Ery. Mean Corpuscular Volume week 12 | Ery. Mean Corpuscular Volume week 18 | Ery. Mean Corpuscular Volume week 24 | Erythrocytes week 0 | Erythrocytes week 6 | Erythrocytes week 12 | Erythrocytes week 18 | Erythrocytes week 24 | Hematocrit week 0 | Hematocrit week 6 | Hematocrit week 12 | Hematocrit week 18 | Hematocrit week 24 | Hemoglobin week 0 | Hemoglobin week 6 | Hemoglobin week 12 | Hemoglobin week 18 | Hemoglobin week 24 | Lymphocytes/Leukocytes week 0 | Lymphocytes/Leukocytes week 6 | Lymphocytes/Leukocytes week 12 | Lymphocytes/Leukocytes week 18 | Lymphocytes/Leukocytes week 24 | Neutrophils, Segmented/Leukocytes week 0 | Neutrophils, Segmented/Leukocytes week 6 | Neutrophils, Segmented/Leukocytes week 12 | Neutrophils, Segmented/Leukocytes week 18 | Neutrophils, Segmented/Leukocytes week 24 | Neutrophils/Leukocytes week 0 | Neutrophils/Leukocytes week 6 | Neutrophils/Leukocytes week 12 | Neutrophils/Leukocytes week 18 | Neutrophils/Leukocytes week 24 | Platelets week 0 | Platelets week 6 | Platelets week 12 | Platelets week 18 | Platelets week 24 |
|---|
Pla/Ros | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 1 | 0 | 2 | 3 | 2 | 3 | 1 | 3 | 3 | 3 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
,| Pla/Ros >ULN | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
,Ros/Pla | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
,| Ros/Pla >ULN | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Trough Concentrations
Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase. (NCT02226198)
Timeframe: Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)
| Intervention | ng/mL (Mean) |
|---|
| Cross-over Phase | 7.387 |
| Maintenance Phase | 4.482 |
TG (mg/dL)
Efficacy in terms of triglycerides (TG) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mg/dL (Mean) |
|---|
| C-FAS Rosuvastatin | 79.8 |
| C-FAS Placebo | 119.5 |
TC/HDL C
Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | ratio (Mean) |
|---|
| C-FAS Rosuvastatin | 13.704 |
| C-FAS Placebo | 17.416 |
TC (mmol/L)
Efficacy in terms of total cholesterol (TC) (NCT02226198)
Timeframe: Samples taken at Day 42 (week 6) and Day 84 (week 12)
| Intervention | mmol/L (Mean) |
|---|
| C-FAS Rosuvastatin | 11.59 |
| C-FAS Placebo | 13.96 |
"Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time t (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291"
Rate and extent of absorption of rosuvastatin by assessment of AUC0-t. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | ng*h/mL (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 130.6 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 183.7 |
Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of CL/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | Litre / h (L/h) (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 143.8 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 107.7 |
Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together
Rate and extent of absorption for AZD9291 by assessment of CLss/F after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.
| Intervention | L/h (Geometric Mean) |
|---|
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 10.14 |
Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of Vz/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | L (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 3890 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 2874 |
Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | ng * h o u r per mL (ng*h/mL ) (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 139.1 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 185.7 |
Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 [Period 1] and Day 32 [Period 3], respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | nanogram per millilitre (ng/mL) (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 13.96 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 24.03 |
Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of t1/2(lambda_z). Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | h (Geometric Mean) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 18.75 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 18.51 |
Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291
Rate and extent of absorption of rosuvastatin by assessment of tmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively). (NCT02317016)
Timeframe: Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.
| Intervention | h (Median) |
|---|
| Rosuvastatin Alone (Period 1 [Day 1]) | 2.05 |
| AZD9291 + Rosuvastatin (Period 3 [Day 32]) | 2.07 |
Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)
After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz. (NCT02401256)
Timeframe: Single dose pharmacokinetics (PK) versus multiple doses (after 17 day pretreatment) PK (total 38 days for each subject)
| Intervention | h*uM (Mean) |
|---|
| Efavirenz AUC0-inf (Single Dose) | Efavirenz AUC0-24 (Multiple Dose) |
|---|
| CYP2B6*1/*1 | 411.53 | 183.97 |
,| CYP2B6*1/*6 | 620.36 | 254.40 |
,| CYP2B6*6/*6 | 522.42 | 321.86 |
Safety and Tolerability in Terms of Abnormal Vital Signs
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 2 | 1 | 2 | 1 | 2 | 2 | 1 | 3 | 3 | 2 | 1 |
,| Sequence B | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 |
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 0 |
,| Sequence B | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| Sequence B | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN)
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 0 |
,| Sequence B | 0 | 1 | 1 | 1 | 1 | 2 | 1 | 3 | 1 | 1 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 2 |
,| Sequence B | 3 | 2 | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 2 | 0 | 2 | 1 | 2 | 1 | 1 | 1 | 2 | 2 | 0 |
,| Sequence B | 3 | 2 | 2 | 2 | 3 | 3 | 4 | 4 | 3 | 3 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 2 |
,| Sequence B | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 3 | 3 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 1 | 0 | 1 | 0 | 2 | 2 | 1 | 1 | 2 | 1 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 2 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 2 | 3 | 2 | 3 | 1 | 1 | 2 | 2 | 1 | 1 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 2 | 2 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,| Sequence B | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 1 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Growth, Height
(NCT02434497)
Timeframe: 96 weeks
| Intervention | cm (Mean) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 142.5 | 143.5 | 144.0 | 145.3 | 145.8 | 147.0 | 148.8 | 158.0 | 159.0 | 159.7 | 165.0 |
,| Sequence B | 136.8 | 136.8 | 137.6 | 138.0 | 139.2 | 140.6 | 142.2 | 144.0 | 145.0 | 148.3 | 138.0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 |
,| Sequence B | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 |
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
,| Sequence B | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 0 |
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal ECG, Abnormalities
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 24 | Final Visit |
|---|
| Sequence A | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 |
Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | ng/mL (Number) |
|---|
| Day 292 | Day 376 |
|---|
| Full Analysis Set | 9.00 | 7.14 |
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline TG (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -17.3 | -17.4 | -16.2 | -22.0 | -23.3 | -21.7 | -28.5 |
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline TC (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -19.4 | -16.8 | -14.0 | -11.8 | -19.9 | -18.3 | -11.9 |
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline TC/HDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -30.6 | -29.4 | -20.5 | -16.6 | -24.1 | -29.2 | -15.6 |
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline Non-HDL-C/HDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -32.9 | -31.5 | -22.3 | -18.1 | -26.3 | -31.8 | -17.6 |
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline Non-HDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -21.7 | -19.2 | -15.7 | -13.3 | -22.1 | -21.0 | -13.2 |
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline LDL-C/HDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -39.4 | -41.2 | -36.1 | -35.0 | -48.6 | -42.2 | -27.8 |
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline LDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -21.0 | -18.6 | -14.7 | -12.1 | -21.3 | -20.5 | -12.4 |
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline HDL-C (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | 12.3 | 19.0 | 5.2 | 4.4 | 4.4 | 9.4 | 3.8 |
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline ApoB/ApoA-1 (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -23.3 | -22.1 | -18.9 | -15.7 | -17.0 | -26.0 | -14.7 |
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline ApoB (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | -20.5 | -18.7 | -15.2 | -10.5 | -17.2 | -19.2 | -9.5 |
The Number of Participants Who Experianced Adverse Events and Serious Adverse Events
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Full Analysis Set | 5 |
Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Full Analysis Set | 0 |
Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Full Analysis Set | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
(NCT02434497)
Timeframe: Up to 22 months
| Intervention | % change from baseline ApoA-1 (Geometric Mean) |
|---|
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 |
|---|
| Full Analysis Set | 8.0 | 7.0 | 5.3 | 6.5 | 1.0 | 10.7 | 1.6 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) (NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 2 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Sequence B | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN
(NCT02434497)
Timeframe: 96 weeks
| Intervention | participants (Number) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
,| Sequence B | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
Safety and Tolerability in Terms of Growth, Weight
(NCT02434497)
Timeframe: 96 weeks
| Intervention | kg (Mean) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | 36.25 | 37.20 | 37.93 | 38.85 | 39.15 | 39.98 | 41.00 | 48.47 | 48.43 | 50.17 | 57.35 |
,| Sequence B | 37.42 | 38.02 | 38.16 | 38.40 | 39.00 | 39.88 | 41.16 | 41.80 | 42.10 | 45.28 | 33.55 |
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score)
Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean. (NCT02434497)
Timeframe: 96 weeks
| Intervention | standard deviations (Mean) |
|---|
| Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
|---|
| Sequence A | -0.43 | -0.48 | -0.41 | -0.43 | -0.60 | -0.43 | -0.16 | 0.05 | 0.00 | 0.08 | 1.18 |
,| Sequence B | -1.05 | -1.05 | -1.19 | -1.14 | -0.96 | -0.76 | -0.72 | -1.04 | -0.87 | -0.33 | -0.51 |
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here. (NCT02476006)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96
| Intervention | units on a scale (Mean) |
|---|
| Self Image: Week 4 | Self Image: Week 8 | Self Image: Week 12 | Self Image: Week 24 | Self Image: Week 48 | Self Image: Week 72 | Self Image: Week 96 | Injection-site reactions: Week 4 | Injection-site reactions: Week 8 | Injection-site reactions: Week 12 | Injection-site reactions: Week 24 | Injection-site reactions: Week 48 | Injection-site reactions: Week 72 | Injection-site reactions: Week 96 | Ease of use: Week 4 | Ease of use: Week 8 | Ease of use: Week 12 | Ease of use: Week 24 | Ease of use: Week 48 | Ease of use: Week 72 | Ease of use: Week 96 |
|---|
| Alirocumab | 9.4 | 9.4 | 9.4 | 9.3 | 9.4 | 9.3 | 9.4 | 9.6 | 9.6 | 9.6 | 9.5 | 9.5 | 9.5 | 9.5 | 8.7 | 8.7 | 8.8 | 8.8 | 8.9 | 9.0 | 9.0 |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. (NCT02476006)
Timeframe: From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)
| Intervention | percentage of participants (Number) |
|---|
| Any TEAE | Any treatment emergent SAE | Any TEAE leading to death | Any TEAE leading to treatment discontinuation |
|---|
| Alirocumab | 71.6 | 16.2 | 0.2 | 4.5 |
Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Pre-SIAQ: self-completed before first self-injection & Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence & satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre & Post SIAQ were analyzed on participants belonging to Pre & Post-SIAQ population and are reported. (NCT02476006)
Timeframe: Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96
| Intervention | units on a scale (Mean) |
|---|
| Feelings about injections: Baseline | Feeling about injections: Week 4 | Feeling about injections: Week 8 | Feeling about injections: Week 12 | Feeling about injections: Week 24 | Feeling about injections: Week 48 | Feeling about injections: Week 72 | Feeling about injections: Week 96 | Self confidence: Baseline | Self Confidence: Week 4 | Self Confidence: Week 8 | Self Confidence: Week 12 | Self Confidence: Week 24 | Self Confidence: Week 48 | Self Confidence: Week 72 | Self Confidence: Week 96 | Satisfaction with self injection: Baseline | Satisfaction with self-injections: Week 4 | Satisfaction with self-injections: Week 8 | Satisfaction with self-injections: Week 12 | Satisfaction with self-injections: Week 24 | Satisfaction with self-injections: Week 48 | Satisfaction with self-injections: Week 72 | Satisfaction with self-injections: Week 96 |
|---|
| Alirocumab | 8.6 | 9.1 | 9.1 | 9.2 | 9.2 | 9.2 | 9.2 | 9.3 | 6.9 | 8.0 | 8.1 | 8.1 | 8.0 | 8.1 | 8.3 | 8.4 | 7.2 | 8.5 | 8.7 | 8.7 | 8.6 | 8.7 | 8.8 | 8.8 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 12 were reported. (NCT02476006)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab | 50.2 |
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C <70 mg/dL at Week 12 and/or >=50% reduction from baseline in LDL-C at Week 12 are reported. (NCT02476006)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab | 69.1 |
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12
LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <100 mg/dL (2.59 mmol/L) at week 12 were reported. (NCT02476006)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|
| Alirocumab | 74.6 |
Percent Change From Baseline in Triglycerides at Week 12
Baseline value was defined as the last observation before the first dose of the treatment. (NCT02476006)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Alirocumab | -8.28 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12
Baseline value was defined as the last observation before the first dose of the treatment. (NCT02476006)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Alirocumab | -38.28 |
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Baseline value was defined as the last observation before the first dose of the treatment. (NCT02476006)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Alirocumab | -45.89 |
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
Baseline value was defined as the last observation before the first dose of the treatment. (NCT02476006)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Alirocumab | 4.37 |
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). Baseline value was defined as the last observation before the first dose of the treatment. (NCT02476006)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| Alirocumab | -54.84 |
Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average
The percent change from baseline at final visit for lipid and lipoprotein measurements (LDL-C, total cholesterol, HDL-C, triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) was determined by ANCOVA with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0), the time-weighted average value was calculated as the value multiplied by the number of days since the last assessment, summed for all observations, and divided by the sum of days between all visits. (NCT02546323)
Timeframe: From baseline (Week 0) to end-of-study (Week 104).
| Intervention | Percent change (Least Squares Mean) |
|---|
| LDL-C | Total Cholesterol | HDL-C | Triglycerides | Non-HDL-C | Non-HDL-C/HDL-C |
|---|
| Placebo | 4.62 | 1.49 | 3.41 | 9.36 | 1.19 | -0.38 |
,| Rosuvastatin 20 mg | -34.89 | -23.98 | 7.07 | -9.05 | -32.59 | -34.31 |
Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA
CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the mean of the CIMT for this segment. The annualized rate of change in the MeanMean CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. (NCT02546323)
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
| Intervention | mm/year (Mean) |
|---|
| Rosuvastatin 20 mg | -0.0011 |
| Placebo | 0.0075 |
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb
CIMT measurements were made from ultrasound images of the near and far walls of the right and left carotid bulb. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. (NCT02546323)
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
| Intervention | mm/year (Mean) |
|---|
| Rosuvastatin 20 mg | 0.0067 |
| Placebo | 0.0228 |
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA
CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. (NCT02546323)
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
| Intervention | mm/year (Mean) |
|---|
| Rosuvastatin 20 mg | -0.0031 |
| Placebo | 0.0079 |
Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA
CIMT measurements were made from ultrasound images of the near and far walls of the right and left ICA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits. (NCT02546323)
Timeframe: From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).
| Intervention | mm/year (Mean) |
|---|
| Rosuvastatin 20 mg | 0.0077 |
| Placebo | 0.0120 |
Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)
The percent change from baseline at final visit for lipid and lipoprotein measurements (low-density lipoprotein cholesterol [LDL-C], total cholesterol, high-density lipoprotein cholesterol [HDL-C], triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) and apolipoprotein measurements (apolipoprotein A-I [ApoA-I], apolipoprotein B [ApoB] and ApoB/ApoA-I ratio) was determined by analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0) to the final visit at Week 104, any missing observations were imputed by LOCF. (NCT02546323)
Timeframe: From baseline (Week 0) to end-of-study (Week 104).
| Intervention | Percent change (Least Squares Mean) |
|---|
| LDL-C | Total Cholesterol | HDL-C | Triglycerides | Non-HDL-C | Non-HDL-C/HDL-C | ApoB | ApoA-I | ApoB/ApoA-I |
|---|
| Placebo | 8.99 | 1.29 | 0.48 | 12.38 | 1.82 | 3.23 | 1.91 | 0.96 | 1.63 |
,| Rosuvastatin 20 mg | -26.47 | -20.56 | 5.47 | -7.26 | -27.67 | -28.52 | -24.20 | 3.16 | -25.14 |
Maximum Concentration of Rosuvastatin (Cmax)
This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). (NCT02574845)
Timeframe: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.
| Intervention | nmol/L (Geometric Mean) |
|---|
| REF Alone | 9.04 |
| Treatment 1 | 9.59 |
| Treatment 2 | 9.94 |
| Treatment 3 | 14.0 |
| Treatment 4 | 9.90 |
| Treatment 5 | 10.8 |
Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)
This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). (NCT02574845)
Timeframe: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.
| Intervention | nanomol (nmol) * hour (h) / Litre (L) (Geometric Mean) |
|---|
| REF Alone | 81.5 |
| Treatment 1 | 87.8 |
| Treatment 2 | 88.7 |
| Treatment 3 | 126 |
| Treatment 4 | 91.5 |
| Treatment 5 | 97.2 |
Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)
This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). (NCT02574845)
Timeframe: Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.
| Intervention | nmol*h/L (Geometric Mean) |
|---|
| REF Alone | 99.7 |
| Treatment 1 | 105 |
| Treatment 2 | 102 |
| Treatment 3 | 149 |
| Treatment 4 | 108 |
| Treatment 5 | 115 |
Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mg/dL (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 (Week 76) | Visit 18 (Week 100) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 117.5 | 125.0 | 124.0 | 125.0 | 125.0 | 129.0 | 127.0 |
,| High-Intensity Statin Therapy+RVX000222 | 119.0 | 128.0 | 129.0 | 132.0 | 131.0 | 132.5 | 131.0 |
Incidence of All-cause Mortality
(NCT02586155)
Timeframe: 120 weeks
| Intervention | Participants (Count of Participants) |
|---|
| High-Intensity Statin Therapy+RVX000222 | 61 |
| High-Intensity Statin Therapy+Placebo | 72 |
Incidence of Hospitalization for Congestive Heart Failure (CHF)
(NCT02586155)
Timeframe: 120 weeks
| Intervention | events (Number) |
|---|
| High-Intensity Statin Therapy+RVX000222 | 29 |
| High-Intensity Statin Therapy+Placebo | 48 |
Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 172 weeks
| Intervention | U/L (Median) |
|---|
| Baseline | Visit 3 (Week 2) | Visit 4 (Week 4) | Visit 5 (Week 6) | Visit 6 (Week 8) | Visit 7 (Week 10) | Visit 8 (Week 12) | Visit 9 (Week 16) | Visit 10 (Week 20) | Visit 11 (Week 24) | Visit 12 (Week 28) | Visit 13 (Week 40) | Visit 14 (Week 52) | Visit 15 (Week 64) | Visit 16 (Week 76) | Visit 17 (Week 88) | Visit 18 (Week 100) | Visit 19 (Week 112) | Visit 20 (Week 124) | Visit 21 (Week 136) | Visit 22 (Week 148) | Visit 23 (Week 160) | Visit 24 (Week 172) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 77.0 | 76.0 | 75.0 | 75.0 | 76.0 | 75.0 | 75.0 | 75.0 | 74.0 | 75.0 | 74.0 | 74.0 | 76.0 | 74.5 | 76.0 | 76.0 | 75.0 | 75.0 | 77.0 | 77.0 | 76.0 | 78.0 | 83.0 | 77.0 | 76.0 |
,| High-Intensity Statin Therapy+RVX000222 | 78.0 | 71.0 | 70.0 | 70.0 | 69.0 | 69.0 | 69.0 | 68.0 | 68.0 | 68.0 | 69.0 | 69.0 | 71.0 | 71.0 | 70.0 | 72.0 | 72.0 | 71.0 | 71.0 | 69.5 | 69.0 | 68.0 | 75.5 | 72.0 | 76.0 |
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE
First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted. (NCT02586155)
Timeframe: 120 weeks
| Intervention | events (Number) |
|---|
| CV Death | Non-fatal MI | Hospitalization for CVD events | Stroke |
|---|
| High-Intensity Statin Therapy+Placebo | 42 | 91 | 18 | 15 |
,| High-Intensity Statin Therapy+RVX000222 | 33 | 74 | 22 | 15 |
Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mg/dL (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 (Week 76) | Visit 18 (Week 100) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 66.0 | 68.0 | 68.0 | 69.0 | 72.0 | 72.0 | 71.0 |
,| High-Intensity Statin Therapy+RVX000222 | 66.0 | 68.5 | 70.0 | 70.5 | 70.5 | 68.0 | 70.0 |
Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 52 weeks
| Intervention | mg/dL (Median) |
|---|
| Baseline | Visit 8 (Week 12) | Visit 14 (Week 52) |
|---|
| High-Intensity Statin Therapy+Placebo | 2.740 | 1.805 | 1.580 |
,| High-Intensity Statin Therapy+RVX000222 | 2.875 | 1.755 | 1.710 |
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2)
(NCT02586155)
Timeframe: 120 weeks
| Intervention | ml/min (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 (Week 76) | Visit 18 (Week 100) | LVT |
|---|
| High-Intensity Statin Therapy+Placebo | 48.9 | 53.3 | 52.5 | 54.8 | 56.7 | 53.9 |
,| High-Intensity Statin Therapy+RVX000222 | 51.4 | 53.0 | 52.4 | 50.8 | 46.5 | 52.5 |
Change in Glucose From Baseline Over Time Between and Within Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mmol/L (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 (Week 76) | Visit 18 (Week 100) | LVT | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 7.385 | 7.835 | 7.800 | 7.840 | 7.890 | 7.795 | 7.595 |
,| High-Intensity Statin Therapy+RVX000222 | 7.590 | 7.925 | 7.900 | 7.920 | 8.010 | 8.100 | 7.650 |
Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mmol/L (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 Week 76) | Visit 18 Week 100) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 0.860 | 0.940 | 0.930 | 0.920 | 0.910 | 0.960 | 0.950 |
,| High-Intensity Statin Therapy+RVX000222 | 0.870 | 0.970 | 0.970 | 0.960 | 0.970 | 0.990 | 1.010 |
Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | % of hemoglobin (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 (Week 76) | Visit 18 (Week 100) | LVT | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 7.30 | 7.20 | 7.30 | 7.40 | 7.30 | 7.30 | 7.20 |
,| High-Intensity Statin Therapy+RVX000222 | 7.40 | 7.20 | 7.30 | 7.30 | 7.30 | 7.40 | 7.30 |
Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mmol/L (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 Week 76) | Visit 18 Week 100) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 1.690 | 1.530 | 1.655 | 1.660 | 1.725 | 1.745 | 1.680 |
,| High-Intensity Statin Therapy+RVX000222 | 1.690 | 1.530 | 1.590 | 1.600 | 1.660 | 1.700 | 1.650 |
Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups
(NCT02586155)
Timeframe: 120 weeks
| Intervention | mmol/L (Median) |
|---|
| Baseline | Visit 11 (Week 24) | Visit 14 (Week 52) | Visit 16 Week 76) | Visit 18 Week 100) | Last Visit on Treatment (LVT) | Follow-up |
|---|
| High-Intensity Statin Therapy+Placebo | 1.690 | 1.670 | 1.700 | 1.670 | 1.610 | 1.650 | 1.720 |
,| High-Intensity Statin Therapy+RVX000222 | 1.630 | 1.660 | 1.735 | 1.730 | 1.755 | 1.700 | 1.650 |
Incidence of First Occurrence of Adjudication-Confirmed Four-Point MACE
First occurrence of four-point MACE defined as a single composite endpoint of cardiovascular (CV) death (including undetermined cause of death) or non-fatal myocardial infarction (MI), stroke or hospital admission for congestive heart failure. (NCT02586155)
Timeframe: 120 weeks
| Intervention | events (Number) |
|---|
| CV Death (CVD) | Non-fatal MI | Stroke | First Hospitalization for CHF |
|---|
| High-Intensity Statin Therapy+Placebo | 55 | 94 | 17 | 48 |
,| High-Intensity Statin Therapy+RVX000222 | 45 | 77 | 17 | 29 |
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE
Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted. (NCT02586155)
Timeframe: 120 weeks
| Intervention | events (Number) |
|---|
| CV Death | Non-fatal MI | Stroke |
|---|
| High-Intensity Statin Therapy+Placebo | 42 | 92 | 15 |
,| High-Intensity Statin Therapy+RVX000222 | 34 | 76 | 15 |
Area Under the Concentration-time Curve
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method (NCT02704702)
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
| Intervention | ng*hr/mL (Geometric Mean) |
|---|
| Treatment A(Single Dose) | 690.43 |
| Treatment A(Multiple Dose) | 820.86 |
| Treatment B(Single Dose) | 86.442 |
| Treatment B(Multiple Dose) | 114.55 |
| Treatment C(Single Dose_Fimasartan) | 702.20 |
| Treatment C(Single Dose_Rosuvastatin) | 85.078 |
| Treatment C(Multiple Dose_Fimasartan) | 880.19 |
| Treatment C(Multiple Dose_Rosuvastatin) | 98.957 |
Maximum Observed Concentration
This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated. (NCT02704702)
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
| Intervention | ng/mL (Geometric Mean) |
|---|
| Treatment A(Single Dose) | 289.12 |
| Treatment A(Multiple Dose) | 362.14 |
| Treatment B(Single Dose) | 9.305 |
| Treatment B(Multiple Dose) | 11.706 |
| Treatment C(Single Dose_Fimasartan) | 283.73 |
| Treatment C(Multiple Dose_Fimasartan) | 341.92 |
| Treatment C(Single Dose_Rosuvastatin) | 12.581 |
| Treatment C(Multiple Dose_Rosuvastatin) | 13.687 |
Time to Reach Maximum Observed Plasma Concentration
This Outcome is the time it takes a drug to reach Cmax (NCT02704702)
Timeframe: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
| Intervention | hr (Median) |
|---|
| Treatment A(Single Dose) | 0.749 |
| Treatment A(Multiple Dose) | 0.635 |
| Treatment B(Single Dose) | 2.999 |
| Treatment B(Multiple Dose) | 4.505 |
| Treatment C(Single Dose_Fimasartan) | 0.750 |
| Treatment C(Multiple Dose_Fimasartan) | 0.751 |
| Treatment C(Single Dose_Rosuvastatin) | 2.003 |
| Treatment C(Multiple Dose_Rosuvastatin) | 1.506 |
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis
Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -20.3 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -56.0 |
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -22.7 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -58.1 |
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -22.2 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -57.1 |
Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -17.4 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -45.2 |
Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -16.5 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -43.0 |
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -16.2 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -43.5 |
Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | 1.1 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 3.7 |
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -0.2 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 3.2 |
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis
Adjusted percentages at Week 24 were obtained from multiple imputation approach including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). (NCT02715726)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Ezetimibe 10 mg | 42.1 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 87.0 |
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | 6.5 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 8.3 |
Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. (NCT02715726)
Timeframe: Up to Week 24
| Intervention | percentage of participants (Number) |
|---|
| Ezetimibe 10 mg | 40.5 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 85.1 |
Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -14.9 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -34.2 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -13.8 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -33.9 |
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -20.4 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -49.1 |
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -20.7 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -47.4 |
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -19.4 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -47.0 |
Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis
Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent Change (Mean) |
|---|
| Ezetimibe 10 mg | 6.313 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -30.064 |
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent Change (Mean) |
|---|
| Ezetimibe 10 mg | 3.956 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -30.317 |
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | 6.1 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 7.3 |
Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis
Adjusted means and standard errors at Week 12 were obtained by using multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 12
| Intervention | percent change (Mean) |
|---|
| Ezetimibe 10 mg | -13.585 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -9.965 |
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis
Adjusted means and standard errors at Week 24 were obtained by using multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Mean) |
|---|
| Ezetimibe 10 mg | -14.409 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -14.462 |
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). (NCT02715726)
Timeframe: From Baseline to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Ezetimibe 10 mg | -21.3 |
| Alirocumab 75 mg Q2W/up to 150 mg Q2W | -58.7 |
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN
Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN)
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms
Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN)
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1.4 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)
Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN)
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 1.4 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized (NCT02741245)
Timeframe: up to 14 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 31.4 |
| Rosuvastatin 2.5 mg | 34.7 |
| Rosuvastatin 5.0 mg | 42.3 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 40.8 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 37.5 |
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria. (NCT02741245)
Timeframe: up to 14 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 1.4 |
| Rosuvastatin 5.0 mg | 4.2 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 2.8 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 2.8 |
Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN)
Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)
Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event
An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued due to an AE was summarized. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 2.8 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 1.4 |
Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate. (NCT02741245)
Timeframe: Baseline and Week 12
| Intervention | Percentage Change (Mean) |
|---|
| Ezetimibe 10 mg | -18.7 |
| Rosuvastatin 2.5 mg | -39.8 |
| Rosuvastatin 5.0 mg | -47.2 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | -54.6 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | -60.5 |
Percentage of Participants With Potential Hy's Law Condition
Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkalinephosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL. (NCT02741245)
Timeframe: up to 12 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg | 0.0 |
| Rosuvastatin 2.5 mg | 0.0 |
| Rosuvastatin 5.0 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 2.5 mg | 0.0 |
| Ezetimibe 10 mg+ Rosuvastatin 5.0 mg | 0.0 |
Percentage of Participants Who Had Study Drug Discontinued Due to an AE
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized. (NCT02748057)
Timeframe: up to 52 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg + Rosuvastatin 2.5 mg | 0.9 |
| Ezetimibe 10 mg + Rosuvastatin 5.0 mg | 0.0 |
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized. (NCT02748057)
Timeframe: Baseline (predose) and Week 52
| Intervention | Percentage change (Mean) |
|---|
| Ezetimibe 10 mg + Rosuvastatin 2.5 mg | -33.8 |
| Ezetimibe 10 mg + Rosuvastatin 5.0 mg | -23.9 |
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized. (NCT02748057)
Timeframe: Up to 2 weeks post last dose of study drug (up to 54 weeks)
| Intervention | Percentage of Participants (Number) |
|---|
| Ezetimibe 10 mg + Rosuvastatin 2.5 mg | 72.8 |
| Ezetimibe 10 mg + Rosuvastatin 5.0 mg | 76.2 |
Treatment-emergent Adverse Events
Number of Grade 3 or above adverse events (NCT02841774)
Timeframe: 14 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Moderate Intensity Group | 0 |
| High Intensity Group | 0 |
Mean Percent Change in Fasting LDL-cholesterol
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14 (NCT02841774)
Timeframe: Week 2 and Week 14
| Intervention | Percent decrease (Mean) |
|---|
| Moderate Intensity Group | 15.0 |
| High Intensity Group | 41.6 |
Maximum Concentration of Rosuvastatin (Cmax)
This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nmol/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 8.135 |
| Rosuvastatin (R4) | 7.801 |
Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
| Intervention | nmol·h/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 163.614 |
| Furosemide (R2) | 159.434 |
Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nmol·h/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 17.668 |
| Digoxin (R1) | 18.303 |
Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. CI - confidence interval, gMean - geometric mean. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nanomole hour per liter (nmol·h/L) (Geometric Mean) |
|---|
| Test Cocktail (T) | 11.549 |
| Digoxin (R1) | 11.981 |
Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of furosemide in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
| Intervention | nmol·h/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 156.382 |
| Furosemide (R2) | 160.551 |
Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞)
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nmol·h/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 97.385 |
| Rosuvastatin (R4) | 90.479 |
Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz)
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nmol·h/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 81.925 |
| Rosuvastatin (R4) | 78.016 |
Maximum Concentration of Digoxin (Cmax)
This outcome measure presents the maximum measured concentration of digoxin in plasma (Cmax). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration
| Intervention | nanomole per liter (nmol/L) (Geometric Mean) |
|---|
| Test Cocktail (T) | 1.262 |
| Digoxin (R1) | 1.355 |
Maximum Concentration of Furosemide (Cmax)
This outcome measure presents the maximum measured concentration of furosemide in plasma (Cmax). Standard error presented is actually geometric standard error. (NCT02854527)
Timeframe: Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration
| Intervention | nmol/L (Geometric Mean) |
|---|
| Test Cocktail (T) | 86.275 |
| Furosemide (R2) | 82.990 |
Pulmonary Embolism
Incidence of pulmonary embolism (PE) (NCT02901067)
Timeframe: Within 30 days after injury
| Intervention | Participants (Count of Participants) |
|---|
| Experimental | 0 |
| Control | 3 |
Ventilator Free Days
As measured by ventilator-free days (VFD). VFDs are typically defined as follows (1): VFDs = 0 if subject dies within 28 days of mechanical ventilation. VFDs = 28 - x if successfully liberated from ventilation x days after initiation. VFDs = 0 if the subject is mechanically ventilated for >28 days. (NCT02901067)
Timeframe: Up to 28 days
| Intervention | days (Median) |
|---|
| Experimental | 26 |
| Control | 26 |
All-cause Mortality
Mortality due to any cause was assessed. (NCT02901067)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Experimental | 1 |
| Control | 0 |
Incidence of Acute Lung Injury (ALI)
Based on Berlin Criteria (NCT02901067)
Timeframe: Within two weeks post-injury
| Intervention | percentage of patients (Number) |
|---|
| Experimental | 0 |
| Control | 0 |
Intensive Care Unit (ICU) Days
ICU-free days will be calculated based on (28 - number of days spent in the ICU) formula (NCT02901067)
Timeframe: 28 days
| Intervention | days (Median) |
|---|
| Experimental | 24 |
| Control | 23 |
Incidence of Arterial Thrombotic Complications: Myocardial Infarction (MI) and Cerebrovascular Accident (CVA).
MI and CVA were diagnosed by health care providers and documented in the EMR. (NCT02901067)
Timeframe: Up to 28 days
| Intervention | percentage of patients (Number) |
|---|
| Experimental | 0 |
| Control | 0 |
Incidence of Multiple Organ Failure (MOF)
As measured by Denver MOF score, which grades (from 0-3, with 3 indicating worst dysfunction) four organ systems (lung, kidney, liver, heart), thus varying from 0 to 12 (worst possible dysfunctions) and defines MOF as score > 3. (NCT02901067)
Timeframe: Up to 28 days
| Intervention | percentage of patients (Number) |
|---|
| Experimental | 0 |
| Control | 0 |
Fibrinolysis Phenotypes
Measured by traditional and tissue plasminogen activator (tPA) - Challenge thrombelastography (TEG) lysis at 30 minutes (LY30). (NCT02901067)
Timeframe: During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hours
| Intervention | percentage of patients (Number) |
|---|
| 12 hours | 24 hours | 48 hours | 72 hours | 120 hours | 168 hours |
|---|
| Control | 50 | 57 | 31 | 25 | 25 | 20 |
,| Experimental | 0 | 43 | 25 | 33 | 38 | 33 |
Incidence of VTE
Based on screening duplex ultrasound (US) of legs and central line on day 5 or upon ICU discharge or upon symptoms of VTE (whichever comes first). (NCT02901067)
Timeframe: Day 5 or ICU discharge or upon symptoms of VTE (whichever comes first)
| Intervention | percentage of patients (Number) |
|---|
| Experimental | 0 |
| Control | 22 |
Incidence of Venous Thromboembolism (VTE)
Includes the incidence of both deep venous thrombosis (DVT) and pulmonary embolism (PE) (NCT02901067)
Timeframe: 30 days
| Intervention | percentage of patients (Number) |
|---|
| Experimental | 0 |
| Control | 22.2 |
Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | 12.19 |
| Alirocumab | 21.04 |
Percent Change From Baseline in Lipoprotein (a) at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Mean) |
|---|
| Standard of Care | -17.23 |
| Alirocumab | -55.76 |
Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36
LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | cubic millimeter (mm^3) (Least Squares Mean) |
|---|
| Standard of Care | -4.73 |
| Alirocumab | -5.77 |
Percent Change From Baseline in Fasting Triglycerides at Week 36
Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Mean) |
|---|
| Standard of Care | -8.85 |
| Alirocumab | -18.37 |
Percent Change From Baseline in Lumen Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Mean) |
|---|
| Standard of Care | 1.20 |
| Alirocumab | -0.86 |
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | -14.06 |
| Alirocumab | -54.50 |
Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | -3.14 |
| Alirocumab | -4.79 |
Percent Change From Baseline in Total Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | -7.59 |
| Alirocumab | -35.43 |
Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36
LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent atheroma volume (Least Squares Mean) |
|---|
| Standard of Care | -1.28 |
| Alirocumab | -1.42 |
Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Standard of Care | 4.7 |
| Alirocumab | 8.1 |
Percent Change From Baseline in Apolipoprotein A-1 at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | 4.61 |
| Alirocumab | 11.75 |
Absolute Change From Baseline in Total Cholesterol (TC) at Week 36
LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Standard of Care | -15.2 |
| Alirocumab | -61.7 |
Percent Change From Baseline in Apolipoprotein B at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Standard of Care | -16.61 |
| Alirocumab | -55.13 |
Percent Change From Baseline in External Elastic Membrane Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | percent change (Mean) |
|---|
| Standard of Care | -0.86 |
| Alirocumab | -3.18 |
Number of Participants With Cardiovascular (CV) Adverse Events
The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure. (NCT02984982)
Timeframe: Up to 36 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Cardiovascular death | Myocardial infarction | Ischemic stroke | Unstable angina requiring hospitalization | Congestive heart failure requiring hospitalization | Ischemia led coronary revascularization procedure |
|---|
| Alirocumab | 0 | 2 | 2 | 0 | 0 | 4 |
,| Standard of Care | 0 | 3 | 0 | 0 | 0 | 2 |
Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 12, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Week 12 | Week 36 |
|---|
| Alirocumab | -62.4 | -63.2 |
,| Standard of Care | -9.6 | -15.5 |
Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 12, Week 36
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 36 |
|---|
| Alirocumab | -64.53 | -63.94 |
,| Standard of Care | -7.57 | -13.40 |
Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Standard of Care | 3.8 |
| Alirocumab | 12.0 |
Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Standard of Care | -16.8 |
| Alirocumab | -51.0 |
Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mm^3 (Mean) |
|---|
| Standard of Care | -8.23 |
| Alirocumab | -10.01 |
Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36
Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Mean) |
|---|
| Standard of Care | -26.2 |
| Alirocumab | -35.3 |
Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Mean) |
|---|
| Standard of Care | -10.3 |
| Alirocumab | -15.5 |
Absolute Change From Baseline in Lumen Volume at Week 36
Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mm^3 (Mean) |
|---|
| Standard of Care | -1.25 |
| Alirocumab | -0.93 |
Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36
Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates. (NCT02984982)
Timeframe: Baseline, Week 36
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Standard of Care | -20.3 |
| Alirocumab | -69.2 |
Safety and Tolerability 4
Kidneys injury: mean values of creatinine (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | μmol/l (Mean) |
|---|
| Mean values of creatinine in men baseline | Mean values of creatinine in men in 1 year | Mean values of creatinine in women baseline | Mean values of creatinine in women in 1 year |
|---|
| Pioglitazone + Standard Care | 105.6 | 85.0 | 66.8 | 72.5 |
,| Standard Care | 102.3 | 82.0 | 88.2 | 77.5 |
Percutaneous Coronary Intervention [Coronary Revascularization]
Number of Participants with incidence of percutaneous coronary intervention. (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 0 | 0 |
,| Standard Care | 0 | 0 |
Cardiovascular Hospitalization
Number of Participants with acute coronary syndrome (ACS) or unstable angina (UA) (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 0 | 0 |
,| Standard Care | 0 | 0 |
Level of Insulin Resistance 2
Mean levels of blood glucose (NCT03011775)
Timeframe: Baseline and 6 months
| Intervention | mmol/L (Mean) |
|---|
| Baseline | In 6 month |
|---|
| Pioglitazone + Standard Care | 6.0 | 5.97 |
,| Standard Care | 5.9 | 5.60 |
Carotic Atherosclerotic Lesions
Number of Participants with presence of atherosclerotic plaque of the intima media of common carotid artery greater than 1.4 mm (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 0 | 0 |
,| Standard Care | 0 | 0 |
Сardiovascular Death
Number of Participants with cardiovascular death (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 0 | 0 |
,| Standard Care | 0 | 0 |
Coronary Artery Bypass [Coronary Revascularization]
Number of Participants with revascularization coronary procedures (coronary artery bypass grafting) (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 0 | 0 |
,| Standard Care | 0 | 0 |
Systemic Inflammation Level
Number of Participants with C-reactive protein level above 3 mg/L (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | In 1 year |
|---|
| Pioglitazone + Standard Care | 10 | 12 |
,| Standard Care | 7 | 13 |
Safety and Tolerability 3
Kidney injury: mean values of the microalbuminuria (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | mg/mol (Mean) |
|---|
| Baseline | 1 year |
|---|
| Pioglitazone + Standard Care | 31.44 | 31.10 |
,| Standard Care | 41.1 | 37.70 |
Safety and Tolerability 2
Liver injury: mean levels of total bilirubin (NCT03011775)
Timeframe: Baseline, 6 month and 1 year
| Intervention | μmol/l (Mean) |
|---|
| Baseline | Mean values of total bilirubin in 6 month | Mean values of total bilirubin in 1 year |
|---|
| Pioglitazone + Standard Care | 12.3 | 12.4 | 15.7 |
,| Standard Care | 10.8 | 12.7 | 15.0 |
Safety and Tolerability 1
Liver injury: mean values of ALT (NCT03011775)
Timeframe: Baseline, 6 month and 1 year
| Intervention | units per liter (U/L) (Mean) |
|---|
| Baseline | Mean values of ALT in 6 months | Mean values of ALT in 1 year |
|---|
| Pioglitazone + Standard Care | 23.4 | 27.4 | 19.9 |
,| Standard Care | 26.9 | 26.1 | 23.9 |
Level of Insulin Resistance 1
Oral glucose tolerance test: number of Participants with impaired glucose tolerance (NCT03011775)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Number of Participants with glucose level in the range of 7.8 to 11 mmol/L baseline | Number of Participants with glucose level in the range of 7.8 to 11 mmol/L in 6 month | Number of Participants with glucose level above 11 mmol/L baseline | Number of Participants with glucose level above 11 mmol/L in 6 month |
|---|
| Pioglitazone + Standard Care | 7 | 13 | 10 | 5 |
,| Standard Care | 14 | 16 | 4 | 3 |
Diameter of Stenosis [Carotic Atherosclerotic Lesions]
Mean diameters of the stenosis of the right and left common carotid arteries (NCT03011775)
Timeframe: Baseline and 1 year
| Intervention | mm (Mean) |
|---|
| Mean diameter of the stenosis of the right common carotid artery baseline | Mean diameter of the stenosis of the right common carotid artery in 1 year | Mean diameter of the stenosis of the left common carotid artery baseline | Mean diameter of the stenosis of the left common carotid artery in 1 year |
|---|
| Pioglitazone + Standard Care | 9.8 | 5.0 | 11.6 | 4.1 |
,| Standard Care | 8.7 | 4.8 | 10.1 | 5.6 |
Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCÏ„) of Lanabecestat (LY3314814)
Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCÏ„) of Lanabecestat (LY3314814) (NCT03019549)
Timeframe: Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
| Intervention | hours times nanograms per milliliter (Geometric Mean) |
|---|
| Lanabecestat (LY3314814) | 3650 |
| Rosuvastatin + Lanabecestat (LY3314814) | 3790 |
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin (NCT03019549)
Timeframe: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
| Intervention | hours times nanogram per milliliter (Geometric Mean) |
|---|
| Rosuvastatin | 80 |
| Rosuvastatin + Lanabecestat (LY3314814) | 78 |
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat (NCT03019549)
Timeframe: .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose
| Intervention | nanograms per milliliter (Geometric Mean) |
|---|
| Lanabecestat (LY3314814) | 369 |
| Rosuvastatin + Lanabecestat (LY3314814) | 399 |
Change in Plasma LDL Cholesterol
Before and after 5 weeks of dapagliflozin on rosuvastatin background. (NCT03074630)
Timeframe: 5 weeks
| Intervention | mmol/L (Median) |
|---|
| Dapagliflozin | -0.1 |
Change in Plasma HDL Cholesterol
Change in plasma HDL cholesterol following dapagliflozin (NCT03074630)
Timeframe: 12 weeks
| Intervention | mmol/L (Median) |
|---|
| Dapagliflozin | 0.08 |
Change in Plasma FFA
Change in plasma FFA following dapagliflozin (NCT03074630)
Timeframe: 5 weeks
| Intervention | mmol/L (Median) |
|---|
| Dapagliflozin | 0.20 |
Change in Peripheral Insulin Sensitivity
Before and after 5 weeks of dapagliflozin on rosuvastatin background, measured as glucose disposal during hyperinsulinemic euglycemic clamp (NCT03074630)
Timeframe: 5 weeks
| Intervention | umol/kg/min (Mean) |
|---|
| Dapagliflozin | 1.6 |
Urinary Glucose Excretion
Before and after 5 weeks of dapagliflozin on rosuvastatin background (NCT03074630)
Timeframe: 5 weeks
| Intervention | mg/min (Median) |
|---|
| Dapagliflozin | 44 |
Change in Total Cholesterol
Change in total cholesterol following dapagliflozin (NCT03074630)
Timeframe: 5 weeks
| Intervention | mmol/L (Median) |
|---|
| Dapagliflozin | -0.01 |
Change in Plasma Triglycerides
Change in plasma Triglycerides following dapagliflozin (NCT03074630)
Timeframe: 5 weeks
| Intervention | mmol/L (Median) |
|---|
| Dapagliflozin | 0.10 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T4 vs. R1)
AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 188.11 | 1330.47 | 113.78 |
,| Probenecid + R1 (T4) | 489.28 | 1346.62 | 244.94 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Cimetidine + R1 (T3) vs. R1)
AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Digoxin | Furosemide | Metformin | Rosuvastatin |
|---|
| Cimetidine + R1 (T3) | 19.03 | 196.39 | 2006.60 | 139.54 |
,| Cocktail (R1) | 15.15 | 194.05 | 1532.41 | 129.90 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Probenecid + R1 (T4) vs. R1)
AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Digoxin | Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 13.52 | 177.96 | 1321.20 | 106.69 |
,| Probenecid + R1 (T4) | 14.44 | 483.38 | 1331.83 | 238.16 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Rifampin + R1 (T2) vs. R1)
AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Digoxin | Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 13.61 | 176.85 | 1357.34 | 87.29 |
,| Rifampin + R1 (T2) | 17.89 | 211.82 | 1473.38 | 303.81 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Verapamil + R1 (T1) vs. R1)
AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. Geometric mean (gMean) presented here is an adjusted gMean and standard error (SE) presented is a geometric SE (gSE). (NCT03307252)
Timeframe: Samples were taken within 0:20 hour:minutes (hh:mm) prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Digoxin | Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 13.61 | 176.85 | 1357.34 | 87.29 |
,| Verapamil + R1 (T1) | 13.71 | 165.80 | 1126.22 | 98.98 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T1 vs. R1)
AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 191.29 | 1365.85 | 94.14 |
,| Verapamil + R1 (T1) | 176.44 | 1147.23 | 116.80 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T2 vs. R1)
AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Furosemide | Metformin | Rosuvastatin |
|---|
| Cocktail (R1) | 191.29 | 1365.85 | 94.14 |
,| Rifampin + R1 (T2) | 215.63 | 1482.76 | 320.72 |
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T3 vs. R1)
AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE. (NCT03307252)
Timeframe: Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.
| Intervention | Nanomole*hour/litre (nmol*h/L) (Geometric Mean) |
|---|
| Furosemide | Metformin | Rosuvastatin |
|---|
| Cimetidine + R1 (T3) | 202.17 | 2023.33 | 148.32 |
,| Cocktail (R1) | 200.61 | 1540.21 | 139.21 |
Effect of Rifampin on AUC0-last Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the AUC0-last of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | pg*hr/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 231 | 3140 | 1890 | 1270 | 1760 | 1630 | 854 |
,| Mild Impairment (Period 2) | 182 | 2830 | 2510 | 1850 | 1690 | 1750 | 1040 |
,| Moderate Impairment (Period 2) | 353 | 6830 | 3480 | 2380 | 2420 | 1850 | 1740 |
,| Severe Impairment (Period 2) | 236 | 10400 | 2850 | 1470 | 2220 | 1610 | 1150 |
Effect of Rifampin on Tmax Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the Tmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | hours (Median) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 1.00 | 2.50 | 1.00 | 2.00 | 1.50 | 3.00 | 2.00 |
,| Mild Impairment (Period 2) | 0.50 | 2.50 | 1.00 | 3.00 | 1.00 | 1.75 | 1.00 |
,| Moderate Impairment (Period 2) | 0.75 | 3.00 | 1.00 | 4.00 | 1.50 | 2.50 | 2.00 |
,| Severe Impairment (Period 2) | 0.50 | 3.50 | 1.00 | 3.00 | 0.50 | 1.75 | 1.00 |
Effect of Rifampin on Cmax Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the Cmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | pg/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 81.4 | 351 | 599 | 102 | 405 | 198 | 236 |
,| Mild Impairment (Period 2) | 73.0 | 243 | 819 | 131 | 505 | 215 | 254 |
,| Moderate Impairment (Period 2) | 92.5 | 443 | 860 | 119 | 508 | 174 | 396 |
,| Severe Impairment (Period 2) | 75.4 | 422 | 981 | 88.4 | 531 | 150 | 208 |
Effect of Rifampin on t1/2 Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the t1/2 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | hours (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 4.97 | 6.48 | 6.50 | 16.5 | 2.76 | 3.49 | 6.76 |
,| Mild Impairment (Period 2) | 4.12 | 7.57 | 8.40 | 21.0 | 3.22 | 3.83 | 9.64 |
,| Moderate Impairment (Period 2) | 5.49 | 11.3 | 11.5 | 17.7 | 2.99 | 4.25 | 7.48 |
,| Severe Impairment (Period 2) | 4.14 | 19.4 | 6.99 | 17.2 | 3.14 | 4.56 | 4.89 |
Effect of Rifampin on AUC0-inf Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the AUC0-inf of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include data from the end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | pg*hr/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 239 | 3290 | 1910 | 1340 | 1770 | 1650 | 830 |
,| Mild Impairment (Period 2) | 189 | 3040 | 2530 | 1930 | 1710 | 1760 | 1060 |
,| Moderate Impairment (Period 2) | 359 | 7240 | 3500 | 2500 | 2430 | 1870 | 1800 |
,| Severe Impairment (Period 2) | 244 | 10700 | 2850 | 1560 | 2240 | 1620 | 1240 |
Effect of Rifampin on CL/F Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the CL/F of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvatatin. CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | liters/hour (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Atorvastatin | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 41.8 | 85.6 | 5.24 | 56.4 | 57.9 |
,| Mild Impairment (Period 2) | 53.0 | 92.8 | 3.95 | 58.6 | 47.1 |
,| Moderate Impairment (Period 2) | 27.8 | 38.9 | 2.86 | 41.1 | 28.9 |
,| Severe Impairment (Period 2) | 40.5 | 26.3 | 3.57 | 44.2 | 38.6 |
Effect of Rifampin on AUC0-24 Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the AUC0-24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | pg*hr/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 234 | 3030 | 1860 | 1000 | 1760 | 1620 | 842 |
,| Mild Impairment (Period 2) | 186 | 2660 | 2460 | 1490 | 1700 | 1720 | 1010 |
,| Moderate Impairment (Period 2) | 346 | 5480 | 3360 | 1780 | 2420 | 1800 | 1670 |
,| Severe Impairment (Period 2) | 238 | 6540 | 2760 | 1070 | 2230 | 1580 | 1100 |
Area Under the Plasma Concentration-time Curve From Time 0 to Last (AUC0-last) Post-dose Period 1
AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. This is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | pg*hr/mL (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 105 | 3740 | 649 | 1060 | 298 | 126 | 171 |
,| Healthy Control | 264 | 1410 | 483 | 1450 | 255 | 152 | 181 |
,| Mild Impairment | 167 | 1440 | 643 | 1490 | 295 | 221 | 231 |
,| Moderate Impairment | 344 | 4230 | 950 | 2020 | 459 | 256 | 479 |
,| Severe Impairment | 248 | 7450 | 602 | 1570 | 419 | 176 | 269 |
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1
AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease (ESRD) requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | pg*hr/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 110 | 5370 | 676 | 1100 | 329 | 163 | 208 |
,| Healthy Control | 273 | 1580 | 520 | 1540 | 292 | 208 | 292 |
,| Mild Impairment | 176 | 1610 | 688 | 1610 | 329 | 286 | 262 |
,| Moderate Impairment | 364 | 4550 | 1020 | 2240 | 511 | 273 | 575 |
,| Severe Impairment | 260 | 7900 | 648 | 1680 | 476 | 226 | 365 |
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Post-dose Period 1
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
| Intervention | pg*hr/mL (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 106 | 2100 | 593 | 858 | 287 | 115 | 162 |
,| Healthy Control | 252 | 1440 | 415 | 1010 | 198 | 108 | 153 |
,| Mild Impairment | 168 | 1380 | 543 | 1040 | 219 | 139 | 191 |
,| Moderate Impairment | 317 | 3440 | 764 | 1280 | 329 | 143 | 343 |
,| Severe Impairment | 235 | 4470 | 525 | 1100 | 300 | 112 | 223 |
Apparent Volume of Distribution During the Terminal Phase (Vz/F) Post-dose Period 1
Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. Vz/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | liters (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Atorvastatin | Rosuvastatin |
|---|
| End-Stage Renal Disease | 579 | 3140 | 252 | 3520 | 4870 |
,| Healthy Control | 422 | 1730 | 495 | 7380 | 4010 |
,| Mild Impairment | 555 | 2120 | 405 | 7300 | 4270 |
,| Moderate Impairment | 409 | 1060 | 317 | 5240 | 3120 |
,| Severe Impairment | 433 | 1230 | 454 | 5310 | 3720 |
Apparent Plasma Terminal Half-life (t1/2) Post-dose Period 1
T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | hours (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 4.41 | 41.4 | 11.8 | 11.0 | 8.03 | 12.4 | 14.0 |
,| Healthy Control | 7.99 | 6.75 | 17.8 | 18.5 | 14.9 | 21.2 | 16.2 |
,| Mild Impairment | 6.76 | 8.40 | 19.3 | 20.5 | 16.7 | 22.8 | 15.5 |
,| Moderate Impairment | 10.3 | 11.9 | 22.4 | 22.0 | 18.6 | 24.6 | 24.9 |
,| Severe Impairment | 7.79 | 24.0 | 20.4 | 18.1 | 17.5 | 21.9 | 18.8 |
Apparent Clearance After Extravascular Administration (CL/F) Post-dose Period 1
CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. CL/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | liters/hour (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Atorvastatin | Rosuvastatin |
|---|
| End-Stage Renal Disease | 90.8 | 52.5 | 14.8 | 304 | 240 |
,| Healthy Control | 36.6 | 178 | 19.2 | 343 | 171 |
,| Mild Impairment | 56.9 | 175 | 14.5 | 304 | 191 |
,| Moderate Impairment | 27.5 | 61.8 | 9.84 | 196 | 87.0 |
,| Severe Impairment | 38.5 | 35.7 | 15.4 | 210 | 137 |
Effect of Rifampin on Vz/F Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the Vz/F of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose
| Intervention | liters (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Atorvastatin | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 300 | 800 | 49.2 | 225 | 565 |
,| Mild Impairment (Period 2) | 315 | 1010 | 47.8 | 272 | 654 |
,| Moderate Impairment (Period 2) | 220 | 632 | 47.3 | 177 | 313 |
,| Severe Impairment (Period 2) | 242 | 733 | 36.0 | 200 | 272 |
Effect of Rifampin on C24 Post-dose Period 2
To evaluate the effect of a single oral dose of rifampin on the C24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. C24 is a measure of the plasma study drug concentration 24 hours post-dose. C24 is reported as median (minimum and maximum) in severe renal impairment arm due to zero values. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2. (NCT03311841)
Timeframe: 24 hours post-dose
| Intervention | pg/mL (Geometric Least Squares Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| Healthy Control (Period 2) | 0.601 | 27.5 | 4.72 | 17.1 | 1.35 | 5.57 | 2.42 |
,| Mild Impairment (Period 2) | 0.00 | 31.1 | 4.70 | 20.7 | 1.76 | 6.28 | 4.18 |
,| Moderate Impairment (Period 2) | 1.42 | 100 | 10.5 | 34.0 | 2.98 | 9.96 | 6.97 |
,| Severe Impairment (Period 2) | 0.394 | 174 | 7.01 | 21.3 | 2.98 | 7.23 | 4.47 |
Time to Maximum Plasma Concentration (Tmax) Post-dose Period 1
Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | hours (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 0.50 | 2.00 | 0.50 | 2.50 | 0.25 | 5.00 | 3.00 |
,| Healthy Control | 1.00 | 1.50 | 0.75 | 2.00 | 0.50 | 6.00 | 3.50 |
,| Mild Impairment | 0.50 | 1.50 | 0.52 | 2.00 | 0.25 | 6.00 | 2.00 |
,| Moderate Impairment | 0.50 | 2.50 | 1.00 | 2.50 | 0.25 | 6.00 | 4.00 |
,| Severe Impairment | 0.50 | 3.00 | 0.50 | 4.00 | 0.25 | 6.00 | 4.00 |
Plasma Concentration at 24 Hours (C24) Post-dose Period 1
C24hr is a measure of the plasma study drug concentration 24 hours post-dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 24 hours post-dose
| Intervention | pg/mL (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 0.283 | 70.2 | 6.07 | 12.9 | 4.28 | 3.67 | 2.64 |
,| Healthy Control | 1.57 | 7.70 | 4.10 | 21.7 | 3.85 | 3.08 | 1.94 |
,| Mild Impairment | 0.734 | 18.7 | 5.32 | 22.4 | 5.04 | 5.02 | 3.59 |
,| Moderate Impairment | 2.64 | 59.3 | 8.13 | 32.8 | 6.03 | 4.43 | 6.01 |
,| Severe Impairment | 1.83 | 107 | 4.04 | 23.2 | 5.73 | 3.25 | 3.40 |
Maximum Plasma Concentration (Cmax) Post-dose Period 1
Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. (NCT03311841)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose
| Intervention | pg/mL (Geometric Mean) |
|---|
| Midazolam | Dabigatran | Pitavastatin | Pitavastatin lactone (metabolite) | Atorvastatin | Ortho-hydroxyatorvastatin (metabolite) | Rosuvastatin |
|---|
| End-Stage Renal Disease | 39.9 | 132 | 242 | 78.5 | 63.7 | 8.58 | 22.5 |
,| Healthy Control | 73.2 | 183 | 164 | 88.1 | 21.6 | 7.67 | 21.5 |
,| Mild Impairment | 70.7 | 153 | 244 | 105 | 31.9 | 8.50 | 23.6 |
,| Moderate Impairment | 77.2 | 312 | 303 | 106 | 55.0 | 9.50 | 40.4 |
,| Severe Impairment | 68.4 | 319 | 218 | 95.4 | 46.7 | 7.22 | 24.4 |
Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period
The aim of the patient perspective questionnaire (completed by the participant after the last injection) was to generate data to support an understanding of the participant experience and satisfaction associated with use of the large volume SYDNEY to administer the 300 mg dose. The questionnaire consisted of 6 questions about level of satisfaction with various aspects of the SYDNEY; with response to each question ranging from 1 (very dissatisfied) to 10 (very satisfied), with higher scores indicated more satisfaction. An additional question (confidence that Sydney device was used correctly) regarding confidence of use of SYDNEY device in the study was evaluated on a scale of 10; where 1 being not at all confident, to 10 being very confident, higher scores indicated more confidence. (NCT03415178)
Timeframe: At Week 12
| Intervention | score on a scale (Mean) |
|---|
| Size of the auto-injector | Ease of holding the auto-injector in hand | 2-step operation:remove cap, press AI against skin | Length of time it took to complete the injection | Fact that needle is hidden prior & after injection | Once monthly injection | Confidence that Sydney device was used correctly |
|---|
| New Auto-Injector Device (SYDNEY) | 9.7 | 9.8 | 9.9 | 9.9 | 10.0 | 10.0 | 9.9 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period
(NCT03415178)
Timeframe: From Baseline to Weeks 8, 12, and 16
| Intervention | percent change (Mean) |
|---|
| Week 8 | Week 12 | Week 16 |
|---|
| New Auto-Injector Device (SYDNEY) | -53.737 | -58.610 | -56.991 |
Percentage of Participants With a SYDNEY or Current Auto-Injector (AI)-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Supervised Injections on Week 0 (Day 1): Parallel-Arm Period
"A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of participants With a SYDNEY-associated PTC (for the reporting arm Alirocumab from new auto-injector device) or Current AI-Associated PTCs (for the reporting arm alirocumab from AI device) are reported." (NCT03415178)
Timeframe: Week 0 (Day 1)
| Intervention | percentage of participants (Number) |
|---|
| Overall | Type: Device-related | Type: Participant-related | Type: Undetermined |
|---|
| Auto-Injector Device (AI) | 0 | 0 | 0 | 0 |
,| New Auto-Injector Device (SYDNEY) | 0 | 0 | 0 | 0 |
Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period
"A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of Participants With a SYDNEY-associated PTC (for the reporting arm Alirocumab from new auto-injector device [SYDNEY]) are reported." (NCT03415178)
Timeframe: From Week 4 up to Week 12
| Intervention | percentage of participants (Number) |
|---|
| Overall | Type: Device-related | Type: Participant-related | Type: Undetermined |
|---|
| New Auto-Injector Device (SYDNEY) | 1.5 | 0 | 1.5 | 0 |
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period
SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an AE. (NCT03415178)
Timeframe: From Week 4 up to Week 12
| Intervention | percentage of PTCs (Number) |
|---|
| Device-related | Participant-related | Undetermined |
|---|
| New Auto-Injector Device (SYDNEY) | 0 | 0.5 | 0 |
Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period
SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an adverse event (AE). Overall category included total of all 3 types of PTCs. The percentage of SYDNEY-associated PTCs was calculated as: Number of PTCs / Number of unsupervised injections*100. The confidence interval (CI) was calculated using the Wilson score method. (NCT03415178)
Timeframe: From Week 4 up to Week 12
| Intervention | percentage of PTCs (Number) |
|---|
| New Auto-Injector Device (SYDNEY) | 0.5 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab : Parallel-Arm Period
Tmax: Time to reach Cmax. (NCT03415178)
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21
| Intervention | days (Median) |
|---|
| Auto-Injector Device (AI) | 7.00 |
| New Auto-Injector Device (SYDNEY) | 7.00 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab: Single-Arm Period
Tmax: Time to reach Cmax. (NCT03415178)
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection
| Intervention | days (Median) |
|---|
| New Auto-injector Device (SYDNEY) | 7.00 |
Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period
Total PCSK9 concentrations below the LLOQ were set to zero. (NCT03415178)
Timeframe: Week 4
| Intervention | ng/mL (Mean) |
|---|
| Auto-Injector Device (AI) | 3329.7 |
| New Auto-Injector Device (SYDNEY) | 3370.0 |
Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period
Total PCSK9 concentrations below the LLOQ were set to zero. (NCT03415178)
Timeframe: Week 16
| Intervention | ng/mL (Mean) |
|---|
| New Auto-Injector Device (SYDNEY) | 3481.4 |
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period
Number of participants with positive ADA during the TEAE period (time from the second IMP injection up to the day of last IMP injection + 70 days) were determined. Treatment-emergent positive ADA response in Single-arm period defined as 1) participants with no ADA positive response in the Parallel-arm period but with any positive response in the Single-arm period or 2) participants with a positive ADA response at baseline, with less than 4-fold increase in titer in the Parallel-arm period (Pre-existing ADA in Parallel-arm period) and at least a 4- fold increase in titer in the Single-arm period. (NCT03415178)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Pre-existing ADA | Negative ADA status | Treatment-emergent ADA positive |
|---|
| New Auto-Injector Device (SYDNEY) | 0 | 2 | 0 |
Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period
Free PCSK9 concentrations below the lower limit of quantification (LLOQ) were set to zero. (NCT03415178)
Timeframe: Week 4
| Intervention | ng/mL (Mean) |
|---|
| Auto-Injector Device (AI) | 90.1 |
| New Auto-Injector Device (SYDNEY) | 78.3 |
Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Parallel-Arm Period
AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks. (NCT03415178)
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21
| Intervention | ng*day/mL (Mean) |
|---|
| Auto-Injector Device (AI) | 381000 |
| New Auto-Injector Device (SYDNEY) | 414000 |
Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Single-Arm Period
AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks. (NCT03415178)
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection
| Intervention | ng*day/mL (Mean) |
|---|
| New Auto-Injector Device (SYDNEY) | 509000 |
Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period
Free PCSK9 concentrations below the LLOQ were set to zero. (NCT03415178)
Timeframe: Week 16
| Intervention | ng/mL (Mean) |
|---|
| New Auto-Injector Device (SYDNEY) | 88.9 |
Injection Experience Questionnaire at Initial Supervised Injection: Overall Ease of Use Scores: Parallel-Arm Period
Participants were given an injection experience questionnaire to complete after the self-injection they administered using SYDNEY device or current AI device on Day 1, for assessment of user experience and overall ease-of-use. The questionnaire included 9 questions about specific aspects of using the device. Overall ease of use was the 9th question, response of which ranged from 1 (very difficult) to 10 (very easy), with higher score indicated more ease of use. (NCT03415178)
Timeframe: Week 0 (Day 1)
| Intervention | score on a scale (Mean) |
|---|
| Auto-Injector Device (AI) | 9.9 |
| New Auto-injector Device (SYDNEY) | 9.8 |
Injection-Treatment Acceptance Questionnaire (I-TAQ©) After Last Injection (at Week 12) - Overall Acceptance Scores: Single-Arm Period
The I-TAQ© was a well-established and validated questionnaire to measure participant satisfaction with SC auto-injector devices. The I-TAQ© (completed by the participant after the last injection) was self-administered questionnaire administered to participants in order to measure their acceptance of the injection. The overall acceptance is one of the five domain scores. The overall acceptance score ranged from 0 to 100, with 0 indicating low acceptance and 100 indicating high acceptance. (NCT03415178)
Timeframe: At Week 12
| Intervention | score on a scale (Mean) |
|---|
| New Auto-Injector Device (SYDNEY) | 93.08 |
Maximum Serum Alirocumab Concentration Observed - Cmax : Parallel-Arm Period
Cmax: Maximum serum concentration observed. (NCT03415178)
Timeframe: Pre-dose (Week 0) and on Day 7, 14 and 21
| Intervention | nanogram per milliliter (ng/mL) (Mean) |
|---|
| Auto-Injector Device (AI) | 25800 |
| New Auto-Injector Device (SYDNEY) | 26800 |
Maximum Serum Alirocumab Concentration Observed - Cmax : Single-Arm Period
Cmax: maximum serum concentration observed. (NCT03415178)
Timeframe: Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection
| Intervention | ng/mL (Mean) |
|---|
| New Auto-injector Device (SYDNEY) | 31900 |
Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response: Parallel-Arm Period
Anti-drug (alirocumab) antibodies samples were analyzed using a validated electrochemiluminescence assay. Number of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from the first IMP injection to the day before the second IMP injection for participants entered into the single arm period or to 70 days after the first IMP injection, whichever comes first) was determined. Treatment-emergent positive ADA response defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period. (NCT03415178)
Timeframe: Up to Week 4
| Intervention | Participants (Count of Participants) |
|---|
| Auto-Injector Device (AI) | 2 |
| New Auto-Injector Device (SYDNEY) | 1 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4: Parallel-Arm Period
Adjusted least square means and standard errors at Week 4 were calculated from analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group (SYDNEY, AI), as well as the continuous fixed covariate of baseline LDL-C value. (NCT03415178)
Timeframe: From Baseline to Week 4
| Intervention | percent change (Least Squares Mean) |
|---|
| Auto-Injector Device (AI) | -51.2 |
| New Auto-Injector Device (SYDNEY) | -66.2 |
Percentage of Participants Reporting >=15 Percent (%) Reduction in LDL-C Level at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted Percentage were obtained from a multiple imputation approach for handling of missing data including all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | 50.0 | 50.0 | 39.0 |
Percent Change From Baseline in Lipoprotein a (Lp) (a) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 48 regardless of status on-or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | 7.4 | -5.2 | -6.4 |
Percent Change From Baseline in Total Cholesterol (Total-C) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Weeks 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | -1.9 | -6.3 | 5.5 |
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 12, 24 and 48 - ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | -3.9 | -9.2 | 5.7 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Weeks 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 24 | Week 48 |
|---|
| Alirocumab | -10.1 | 4.2 |
Number of Participants With Tanner Staging at Baseline, Weeks 12, 24 and 48
Tanner stage defines physical measurements of development in children and adolescent based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), and classified in 3 categories as: Prepubescent (defined as a person just before start of the development of adult sexual characteristics), Pubescent (defined as a person at or approaching the age of puberty), Postpubescent (sexually mature or a person who has completed puberty). (NCT03510715)
Timeframe: Baseline, Weeks 12, 24 and 48
| Intervention | Participants (Count of Participants) |
|---|
| Baseline: Prepubescent | Baseline: Pubescent | Baseline: Post-pubescent | Week 12: Prepubescent | Week 12: Pubescent | Week 12: Post-pubescent | Week 24: Prepubescent | Week 24: Pubescent | Week 24: Post-pubescent | Week 48: Prepubescent | Week 48: Pubescent | Week 48: Post-pubescent |
|---|
| Alirocumab 150 mg Q2W | 0 | 9 | 0 | 0 | 8 | 1 | 0 | 8 | 1 | 0 | 7 | 2 |
,| Alirocumab 75 mg Q2W/up to 150 mg Q2W | 3 | 6 | 0 | 3 | 6 | 0 | 2 | 6 | 0 | 1 | 7 | 0 |
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Weeks 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | 13.0 | 8.9 | 10.1 |
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | 2.8 | 5.2 | 10.0 |
Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Week 4 to 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | 11.3 | 14.6 | 11.3 |
Percent Change From Baseline in Apolipoprotein (Apo) B at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | -4.2 | -11.8 | 0.9 |
Absolute Change From Baseline in LDL-C Level at Weeks 12, 24 and 48: ITT Analysis/On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). Although separate analyses of all available data (ITT analysis) and only data collected within a defined time window (On-treatment analysis) were planned, if all values used in the ITT approach were within the on-treatment time window, the on-treatment analysis would be identical to the ITT analysis, thus the results would be identical and a single outcome measure presenting the results for both types of analysis would be provided. (NCT03510715)
Timeframe: Baseline to Weeks 12, 24 and 48
| Intervention | mg/dL (Least Squares Mean) |
|---|
| Week 12 | Week 24 | Week 48 |
|---|
| Alirocumab | -33.4 | -43.0 | -15.0 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12: Intent-to-Treat (ITT) Analysis
Adjusted least square (LS) means and standard errors were obtained from the mixed model analysis with repeated measures (MMRM) to account for missing data using all available post-baseline data from Week 4 to Week 48 regardless of status on- or off-treatment used in the model (ITT analysis). (NCT03510715)
Timeframe: Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab | -4.1 |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12: On-treatment Analysis
Adjusted LS means and standard errors were obtained from the MMRM model to account for missing data using all available post-baseline on-treatment data from Week 4 to Week 48 (on-treatment Analysis). (NCT03510715)
Timeframe: Baseline to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| Alirocumab | -4.1 |
DB Period: Percent Change From Baseline in Apolipoprotein A1 at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | -0.1 |
| DB Period: Alirocumab Q2W | -1.7 |
| DB Period: Placebo Q4W | -0.7 |
| DB Period: Alirocumab Q4W | 5.0 |
DB Period: Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 10.4 |
| DB Period: Alirocumab Q2W | -27.4 |
| DB Period: Placebo Q4W | -3.6 |
| DB Period: Alirocumab Q4W | -34.3 |
DB Period: Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 8.9 |
| DB Period: Alirocumab Q2W | -30.0 |
| DB Period: Placebo Q4W | 1.1 |
| DB Period: Alirocumab Q4W | -31.7 |
DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12: ITT Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| DB Period: Placebo Q2W | 6.5 |
| DB Period: Alirocumab Q2W | -2.2 |
| DB Period: Placebo Q4W | 7.8 |
| Db Period: Alirocumab Q4W | -0.3 |
DB Period: Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Mean) |
|---|
| DB Period: Placebo Q2W | 7.7 |
| DB Period: Alirocumab Q2W | 11.9 |
| DB Period: Placebo Q4W | 12.2 |
| DB Period: Alirocumab Q4W | -6.8 |
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | -0.8 |
| DB Period: Alirocumab Q2W | 5.6 |
| DB Period: Placebo Q4W | -1.1 |
| DB Period: Alirocumab Q4W | 3.4 |
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | -2.2 |
| DB Period: Alirocumab Q2W | 3.5 |
| DB Period: Placebo Q4W | -3.5 |
| DB Period: Alirocumab Q4W | 4.0 |
DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 12. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Mean) |
|---|
| DB Period: Placebo Q2W | -7.1 |
| DB Period: Alirocumab Q2W | -12.7 |
| DB Period: Placebo Q4W | -2.5 |
| DB Period: Alirocumab Q4W | -16.0 |
DB Period: Percent Change From Baseline in Lipoprotein (a) at Week 24: ITT Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Mean) |
|---|
| DB Period: Placebo Q2W | 0.5 |
| DB Period: Alirocumab Q2W | -14.7 |
| DB Period: Placebo Q4W | 2.5 |
| DB Period: Alirocumab Q4W | -22.4 |
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24: Intent-to-treat (ITT) Estimand
Adjusted least square (LS) means and standard errors (SE) were obtained from mixed-effect model with repeated measures (MMRM) model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 9.7 |
| DB Period: Alirocumab Q2W | -33.6 |
| DB Period: Placebo Q4W | -4.4 |
| DB Period: Alirocumab Q4W | -38.2 |
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 10.7 |
| DB Period: Alirocumab Q2W | -34.8 |
| DB Period: Placebo Q4W | 2.3 |
| DB Period: Alirocumab Q4W | -39.2 |
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 9.7 |
| DB Period: Alirocumab Q2W | -31.0 |
| DB Period: Placebo Q4W | -3.7 |
| DB Period: Alirocumab Q4W | -35.6 |
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 9.8 |
| DB Period: Alirocumab Q2W | -33.0 |
| DB Period: Placebo Q4W | 2.8 |
| DB Period: Alirocumab Q4W | -34.7 |
DB Period: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 7.4 |
| DB Period: Alirocumab Q2W | -23.4 |
| DB Period: Placebo Q4W | -4.4 |
| DB Period: Alirocumab Q4W | -27.7 |
DB Period: Percent Change From Baseline in Total Cholesterol at Week 12: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model including all available post-baseline data. All post-baseline data available up to Week 12 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | 7.5 |
| DB Period: Alirocumab Q2W | -25.3 |
| DB Period: Placebo Q4W | 0.9 |
| DB Period: Alirocumab Q4W | -27.0 |
DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 12: ITT Estimand
Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data for Q4W. All available post-baseline data up to Week 12 were included in the imputation model. For Q2W, adjusted percentages at Week 12 were obtained from last observation carried forward approach (LOCF) to handle missing on-treatment LDL-C values as well as missing post-treatment LDL-C values in participants who discontinued treatment due to the coronavirus disease-2019 pandemic. Other post-treatment missing values were considered as failure. (NCT03510884)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|
| DB Period: Placebo Q2W | 0.0 |
| DB Period: Alirocumab Q2W | 61.2 |
| DB Period: Placebo Q4W | 4.3 |
| DB Period: Alirocumab Q4W | 57.0 |
DB Period: Percentage of Participants Achieving Low Density Lipoprotein Cholesterol <110 mg/dL (2.84 mmol/L) at Week 24: ITT Estimand
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model. (NCT03510884)
Timeframe: At Week 24
| Intervention | percentage of participants (Number) |
|---|
| DB Period: Placebo Q2W | 4.0 |
| DB Period: Alirocumab Q2W | 57.2 |
| DB Period: Placebo Q4W | 9.0 |
| DB Period: Alirocumab Q4W | 67.2 |
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level <130 mg/dL (3.37 mmol/L) at Week 12: ITT Estimand
Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 12 were included in the imputation model. (NCT03510884)
Timeframe: At Week 12
| Intervention | percentage of participants (Number) |
|---|
| DB Period: Placebo Q2W | 16.4 |
| DB Period: Alirocumab Q2W | 70.6 |
| DB Period: Placebo Q4W | 12.9 |
| DB Period: Alirocumab Q4W | 72.6 |
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol Level Lower Than (<) 130 mg/dL (3.37 mmol/L) at Week 24: ITT Estimand
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data up to Week 24 were included in the imputation model. (NCT03510884)
Timeframe: At Week 24
| Intervention | percentage of participants (Number) |
|---|
| DB Period: Placebo Q2W | 8.0 |
| DB Period: Alirocumab Q2W | 73.3 |
| DB Period: Placebo Q4W | 22.2 |
| DB Period: Alirocumab Q4W | 76.3 |
OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: ITT Estimand
Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure. (NCT03510884)
Timeframe: Baseline, Week 104
| Intervention | percent change (Least Squares Mean) |
|---|
| OL Period: Placebo/Alirocumab Q2W | -23.3 |
| OL Period: Alirocumab Q2W | -22.2 |
| OL Period: Placebo/Alirocumab Q4W | -27.1 |
| OL Period: Alirocumab Q4W | -23.7 |
OL Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Week 104: On-treatment Estimand
Percent Change in LDL-C from Baseline to Week 104 was reported in this outcome measure. (NCT03510884)
Timeframe: Baseline, Week 104
| Intervention | percent change (Least Squares Mean) |
|---|
| OL Period: Placebo/Alirocumab Q2W | -22.8 |
| OL Period: Alirocumab Q2W | -25.8 |
| OL Period: Placebo/Alirocumab Q4W | -27.6 |
| OL Period: Alirocumab Q4W | -23.4 |
Change From Baseline in Cogstate Battery Test - Overall Composite Score at Weeks 24, 68 and 104
Cogstate battery test (cognitive testing system) consisted of detection test (DET), identification test (IDN), one card learning test (OCL) and Groton maze learning test (GML) to assess processing speed, attention, visual learning and executive functioning, respectively. For each test, Z-scores were computed based on participant's age at Baseline and Weeks 24, 68 and 104. Composite score: calculated as mean of Z-scores equally weighted, provided that at least 3 of 4 tests were available and if all of these domains were covered as: attention, through either DET or IDN, visual learning, through OCL and executive function, through GML. There is not minimum/maximum since values were reported as z-score but z-score of 0 means result equals to mean with negative numbers indicating values lower than mean and positive values higher. Positive change in z-score = an improvement in cognition, i.e., a better outcome; and negative change in z-score = worsening in cognition, i.e., a worse outcome. (NCT03510884)
Timeframe: Baseline, Weeks 24, 68 and 104
| Intervention | Z-score (Mean) |
|---|
| Week 24 | Week 68 | Week 104 |
|---|
| Alirocumab Q2W | -0.313 | -0.334 | -0.439 |
,| Alirocumab Q4W | -0.136 | -0.263 | -0.638 |
,| Placebo/Alirocumab Q2W | -0.403 | -0.421 | -0.601 |
,| Placebo/Alirocumab Q4W | -0.218 | -0.272 | -0.393 |
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 12 and Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12, and 24
| Intervention | ratio (Apo B/Apo A-1) (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -0.2 | -0.2 |
,| DB Period: Alirocumab Q4W | -0.3 | -0.3 |
,| DB Period: Placebo Q2W | 0.1 | 0.1 |
,| DB Period: Placebo Q4W | 0.0 | 0.0 |
DB Period: Percent Change From Baseline in Total Cholesterol at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -25.3 | -23.4 |
,| DB Period: Alirocumab Q4W | -27.0 | -27.7 |
,| DB Period: Placebo Q2W | 7.5 | 7.4 |
,| DB Period: Placebo Q4W | 0.9 | -4.4 |
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 8, Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. (NCT03510884)
Timeframe: Baseline to Weeks 8, 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 8 | Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -35.4 | -34.8 | -33.6 |
,| DB Period: Alirocumab Q4W | -42.0 | -39.2 | -38.2 |
,| DB Period: Placebo Q2W | 7.1 | 10.7 | 9.7 |
,| DB Period: Placebo Q4W | -3.8 | 2.3 | -4.4 |
DB Period: Percent Change From Baseline in Apolipoprotein A1 (Apo A1) at Week 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 24 were used and missing data were accounted for by the MMRM model. MMRM model was run on participants with a Baseline value and a post-baseline value for at least one timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|
| DB Period: Placebo Q2W | -0.1 |
| DB Period: Alirocumab Q2W | 1.0 |
| DB Period: Placebo Q4W | -4.5 |
| DB Period: Alirocumab Q4W | 4.4 |
Number of Participants With Tanner Staging at Baseline and Weeks 24, 68 and 104
Tanner stage defines physical measurements of development in children and adolescent based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males) and classified in 3 categories as: Prepubescent (defined as a person just before start of the development of adult sexual characteristics), Pubescent (defined as a person at or approaching the age of puberty), Postpubescent (sexually mature or a person who has completed puberty). (NCT03510884)
Timeframe: Baseline, Weeks 24, 68 and 104
| Intervention | Participants (Count of Participants) |
|---|
| Baseline: Boys - Prepubescent | Baseline: Boys - Pubescent | Baseline: Boys - Postpubescent | Baseline: Girls - Prepubescent | Baseline: Girls - Pubescent | Baseline: Girls - Postpubescent | Week 24: Boys - Prepubescent | Week 24: Boys - Pubescent | Week 24: Boys - Postpubescent | Week 24: Girls - Prepubescent | Week 24: Girls - Pubescent | Week 24: Girls - Postpubescent | Week 68: Boys - Prepubescent | Week 68: Boys - Pubescent | Week 68: Boys - Postpubescent | Week 68: Girls - Prepubescent | Week 68: Girls - Pubescent | Week 68: Girls - Postpubescent | Week 104: Boys - Prepubescent | Week 104: Boys - Pubescent | Week 104: Boys - Postpubescent | Week 104: Girls - Prepubescent | Week 104: Girls - Pubescent | Week 104: Girls - Postpubescent |
|---|
| Alirocumab Q2W | 4 | 13 | 2 | 4 | 16 | 10 | 3 | 11 | 3 | 4 | 15 | 9 | 1 | 9 | 6 | 3 | 14 | 9 | 1 | 8 | 6 | 0 | 10 | 11 |
,| Alirocumab Q4W | 0 | 14 | 4 | 7 | 13 | 14 | 0 | 12 | 5 | 2 | 16 | 9 | 0 | 9 | 6 | 1 | 16 | 9 | 0 | 8 | 7 | 1 | 17 | 11 |
,| Placebo/Alirocumab Q2W | 1 | 13 | 3 | 1 | 6 | 1 | 0 | 13 | 4 | 1 | 5 | 2 | 0 | 7 | 4 | 0 | 6 | 1 | 0 | 6 | 7 | 0 | 4 | 2 |
,| Placebo/Alirocumab Q4W | 5 | 4 | 3 | 1 | 8 | 6 | 1 | 7 | 3 | 1 | 6 | 5 | 1 | 5 | 3 | 1 | 5 | 5 | 1 | 5 | 2 | 1 | 5 | 5 |
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 130 mg/dL (3.37 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. (NCT03510884)
Timeframe: Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 70.6 | 73.3 |
,| DB Period: Alirocumab Q4W | 72.6 | 76.3 |
,| DB Period: Placebo Q2W | 16.4 | 8.0 |
,| Db Period: Placebo Q4W | 12.9 | 22.2 |
DB Period: Percentage of Participants Who Achieved Low Density Lipoprotein Cholesterol < 110 mg/dL (2.84 mmol/L) at Weeks 12 and 24: On-treatment Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. (NCT03510884)
Timeframe: Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 61.7 | 57.2 |
,| DB Period: Alirocumab Q4W | 57.0 | 67.2 |
,| DB Period: Placebo Q2W | 0.1 | 4.0 |
,| DB Period: Placebo Q4W | 4.3 | 9.0 |
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. (NCT03510884)
Timeframe: At Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 25.2 | 21.6 |
,| DB Period: Alirocumab Q4W | 31.9 | 32.4 |
,| DB Period: Placebo Q2W | 0.0 | 0.0 |
,| DB Period: Placebo Q4W | 0.1 | 9.1 |
DB Period: Percentage of Participants Who Achieved at Least 50% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model. (NCT03510884)
Timeframe: At Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 25.2 | 21.6 |
,| DB Period: Alirocumab Q4W | 31.9 | 32.4 |
,| DB Period: Placebo Q2W | 0.0 | 0.0 |
,| DB Period: Placebo Q4W | 0.1 | 9.1 |
DB Period: Percentage of Participants Who Achieved at Least 30 Percent (%) Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: ITT Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model. (NCT03510884)
Timeframe: At Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 65.8 | 66.7 |
,| DB Period: Alirocumab Q4W | 70.8 | 72.5 |
,| DB Period: Placebo Q2W | 0.8 | 4.0 |
,| DB Period: Placebo Q4W | 4.2 | 18.5 |
DB Period: Percentage of Participants Achieved at Least 30% Reduction in Low Density Lipoprotein Cholesterol Level From Baseline at Weeks 12 and 24: On-treatment Estimand
Adjusted percentages at Weeks 12 and 24 were obtained from multiple imputation approach for handling of missing data followed by logistic regression model. All available post-baseline on-treatment data up to Week 12 and Week 24 were included in the imputation model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. (NCT03510884)
Timeframe: At Weeks 12 and 24
| Intervention | percentage of participants (Number) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 65.8 | 66.7 |
,| DB Period: Alirocumab Q4W | 70.8 | 72.5 |
,| DB Period: Placebo Q2W | 0.8 | 4.0 |
,| DB Period: Placebo Q4W | 4.2 | 18.5 |
DB Period: Percent Change in Low Density Lipoprotein Cholesterol From Baseline to Weeks 8, 12 and 24: ITT Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline data available up to Week 8, Week 12 and Week 24 were used and missing data were accounted for by the MMRM model. (NCT03510884)
Timeframe: Baseline to Weeks 8, 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 8 | Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -35.4 | -34.8 | -33.6 |
,| DB Period: Alirocumab Q4W | -42.0 | -39.2 | -38.2 |
,| DB Period: Placebo Q2W | 7.1 | 10.7 | 9.7 |
,| DB Period: Placebo Q4W | -3.8 | 2.3 | -4.4 |
DB Period: Percent Change From Baseline in Apolipoprotein A1 at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM mode, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -1.7 | 1.0 |
,| DB Period: Alirocumab Q4W | 5.0 | 4.4 |
,| DB Period: Placebo Q2W | -0.1 | -0.1 |
,| DB Period: Placebo Q4W | -0.7 | -4.5 |
DB Period: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -33.0 | -31.0 |
,| Db Period: Alirocumab Q4W | -34.7 | -35.6 |
,| DB Period: Placebo Q2W | 9.8 | 9.7 |
,| DB Period: Placebo Q4W | 2.8 | -3.7 |
DB Period: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Weeks 12, and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st investigational medicinal product (IMP) injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12, and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -34.8 | -33.6 |
,| DB Period: Alirocumab Q4W | -39.2 | -38.2 |
,| DB Period: Placebo Q2W | 10.7 | 9.7 |
,| DB Period: Placebo Q4W | 2.3 | -4.4 |
DB Period: Percent Change From Baseline in Lipoprotein (a) at Weeks 12 and 24: On-treatment Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Weeks 12 and 24
| Intervention | percent change (Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -12.746 | -14.748 |
,| DB Period: Alirocumab Q4W | -16.042 | -22.418 |
,| DB Period: Placebo Q2W | -7.099 | 0.492 |
,| DB Period: Placebo Q4W | -2.545 | 2.468 |
DB Period: Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 day otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12, and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | 3.5 | 5.6 |
,| DB Period: Alirocumab Q4W | 4.0 | 3.4 |
,| DB Period: Placebo Q2W | -2.2 | -0.8 |
,| DB Period: Placebo Q4W | -3.5 | -1.1 |
DB Period: Percent Change From Baseline in Fasting Triglycerides at Weeks 12 and 24: On-treatment Estimand
Adjusted means and standard errors were obtained from a multiple imputation approach followed by a robust regression model including all available post-baseline on-treatment data up to Week 12 and Week 24, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for those who stopped IMP before switch to Q2W regimen, + 21 days otherwise. Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. (NCT03510884)
Timeframe: Baseline, Weeks 12, and 24
| Intervention | percent change (Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -2.2 | 11.9 |
,| DB Period: Alirocumab Q4W | -0.3 | -6.8 |
,| DB Period: Placebo Q2W | 6.5 | 7.7 |
,| DB Period: Placebo Q4W | 7.8 | 12.2 |
DB Period: Percent Change From Baseline in Apolipoprotein B at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12 and 24
| Intervention | percent change (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -30.0 | -27.4 |
,| DB Period: Alirocumab Q4W | -31.7 | -34.3 |
,| DB Period: Placebo Q2W | 8.9 | 10.4 |
,| DB Period: Placebo Q4W | 1.1 | -3.6 |
DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response
Anti-drug (alirocumab) antibodies samples were analyzed using a validated non-quantitative, titer-based bridging immunoassay. Number of participants with positive ADA during 24-week treatment period is reported. Treatment-emergent positive ADA response was defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period. A persistent positive response was defined as a TE ADA positive response detected in at least 2 consecutive post-baseline samples separated by at least a 12-week period. Persistent positive response was only analyzed for participants with positive TE ADA response. (NCT03510884)
Timeframe: Up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| TE ADA positive response | Persistent positive response |
|---|
| DB Period: Alirocumab Q2W | 3 | 0 |
DB Period: Number of Participants With Treatment-Emergent (TE) Positive Anti-Alirocumab Antibodies (ADA) Response
Anti-drug (alirocumab) antibodies samples were analyzed using a validated non-quantitative, titer-based bridging immunoassay. Number of participants with positive ADA during 24-week treatment period is reported. Treatment-emergent positive ADA response was defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period. A persistent positive response was defined as a TE ADA positive response detected in at least 2 consecutive post-baseline samples separated by at least a 12-week period. Persistent positive response was only analyzed for participants with positive TE ADA response. (NCT03510884)
Timeframe: Up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| TE ADA positive response |
|---|
| DB Period: Alirocumab Q4W | 0 |
,| DB Period: Placebo Q2W | 0 |
,| DB Period: Placebo Q4W | 0 |
DB Period: Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 12 and 24: On-treatment Estimand
Adjusted LS means and SE were obtained from MMRM model. All post-baseline on-treatment data available up to Week 12 and Week 24 were used for the MMRM model, i.e., for Q2W data: from 1st IMP injection up to last IMP injection + 21 days and for Q4W data: from 1st IMP injection up to last IMP injection + 35 days for who stopped IMP before switch to Q2W regimen, + 21 days otherwise. MMRM model was run on participants with a Baseline value and at one on-treatment post-baseline value for a timepoint used in the model. (NCT03510884)
Timeframe: Baseline, Weeks 12, and 24
| Intervention | ratio (Apo B/Apo A-1) (Least Squares Mean) |
|---|
| Week 12 | Week 24 |
|---|
| DB Period: Alirocumab Q2W | -0.2 | -0.2 |
,| DB Period: Alirocumab Q4W | -0.3 | -0.3 |
,| DB Period: Placebo Q2W | 0.1 | 0.1 |
,| DB Period: Placebo Q4W | 0.0 | 0.0 |
Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Furosemide)
Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Furosemide (Period 1) | 157.57 |
| Furosemide + BI 730357 (Period 2) | 185.50 |
Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Furosemide)
Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Furosemide (Period 1) | 151.01 |
| Furosemide + BI 730357 (Period 2) | 172.26 |
Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax, Rosuvastatin)
Maximum measured concentration of Rosuvastatin in plasma is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | nanomole / liter (nmol/L) (Geometric Mean) |
|---|
| Rosuvastatin (Period 1) | 6.92 |
| Rosuvastatin + BI 730357 (Period 2) | 9.63 |
Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Digoxin)
Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Digoxin (Period 1) | 13.34 |
| Digoxin + BI 730357 (Period 2) | 22.71 |
Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Digoxin)
Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Digoxin (Period 1) | 11.00 |
| Digoxin + BI 730357 (Period 2) | 19.11 |
Maximum Measured Concentration of Digoxin in Plasma (Cmax, Digoxin)
Maximum measured concentration of Digoxin in plasma is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | nanomole / liter (nmol/L) (Geometric Mean) |
|---|
| Digoxin (Period 1) | 0.87 |
| Digoxin + BI 730357 (Period 2) | 1.40 |
Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Rosuvastatin)
Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Rosuvastatin (Period 1) | 90.08 |
| Rosuvastatin + BI 730357 (Period 2) | 110.87 |
Maximum Measured Concentration of Furosemide in Plasma (Cmax, Furosemide)
Maximum measured concentration of Furosemide in plasma is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h*nmol/L) (Geometric Mean) |
|---|
| Furosemide (Period 1) | 51.03 |
| Furosemide + BI 730357 (Period 2) | 57.21 |
Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Rosuvastatin)
Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean. (NCT04590937)
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
| Intervention | hour * nanomole / liter (h * nmol/L) (Geometric Mean) |
|---|
| Rosuvastatin (Period 1) | 78.83 |
| Rosuvastatin + BI 730357 (Period 2) | 93.54 |
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug, which did not necessarily have a causal relationship with the treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation. (NCT04608344)
Timeframe: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin | 19.2 |
| Pravastatin + Rosuvastatin | 24.0 |
| Filgotinib | 65.4 |
| Filgotinib + Atorvastatin | 7.7 |
| Filgotinib + Pravastatin + Rosuvastatin | 11.5 |
PK Parameter: Cmax of ATV, PRA, and ROS
Cmax is defined as the maximum observed concentration of drug. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | ng/mL (Mean) |
|---|
| PRA | ROS |
|---|
| Filgotinib + Pravastatin + Rosuvastatin | 99.2 | 12.3 |
,| Pravastatin + Rosuvastatin | 84.2 | 7.5 |
PK Parameter: Cmax of ATV, PRA, and ROS
Cmax is defined as the maximum observed concentration of drug. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | ng/mL (Mean) |
|---|
| ATV |
|---|
| Atorvastatin | 19.7 |
,| Filgotinib + Atorvastatin | 15.0 |
PK Parameter: AUCinf of ATV, PRA, and ROS
AUCinf is defined as the concentration of drug extrapolated to infinite time. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | h*ng/mL (Mean) |
|---|
| PRA | ROS |
|---|
| Filgotinib + Pravastatin + Rosuvastatin | 234.8 | 92.3 |
,| Pravastatin + Rosuvastatin | 201.3 | 66.0 |
PK Parameter: AUCinf of ATV, PRA, and ROS
AUCinf is defined as the concentration of drug extrapolated to infinite time. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | h*ng/mL (Mean) |
|---|
| ATV |
|---|
| Atorvastatin | 80.8 |
,| Filgotinib + Atorvastatin | 71.8 |
Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | h*ng/mL (Mean) |
|---|
| PRA | ROS |
|---|
| Filgotinib + Pravastatin + Rosuvastatin | 232.5 | 89.3 |
,| Pravastatin + Rosuvastatin | 199.5 | 62.6 |
Pharmacokinetic (PK) Parameter: AUClast of ATV, PRA, and ROS
AUClast is defined as the concentration of drug from time zero to the last observable concentration. (NCT04608344)
Timeframe: AB (Days 1,3,12,14) and BA (Days 6,8,18,20): Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 postdose; AB (Days 1,12) and BA (Days 6,18): 5,10,36 hours post dose; AB (Days 3,14) and BA (Days 8,20): 72 hours postdose
| Intervention | h*ng/mL (Mean) |
|---|
| ATV |
|---|
| Atorvastatin | 78.8 |
,| Filgotinib + Atorvastatin | 70.2 |
Percentage of Participants With Severity Grade 3 or Above Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 of Adverse Events and Laboratory abnormalities. Laboratory abnormalities were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening), Grade 5 (Death). Percentage of participants with Grade 3 or higher treatment-emergent laboratory abnormalities were reported. (NCT04608344)
Timeframe: Sequence AB: First dose up to 47 days, Sequence BA: First dose up to 50 days
| Intervention | percentage of participants (Number) |
|---|
| Atorvastatin | 0 |
| Pravastatin + Rosuvastatin | 0 |
| Filgotinib | 3.8 |
| Filgotinib + Atorvastatin | 0 |
| Filgotinib + Pravastatin + Rosuvastatin | 0 |
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. (NCT04621227)
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
| Intervention | Participants (Count of Participants) |
|---|
| Rosuvastatin 10mg (Period 1) | 0 |
| Midazolam 2mg (Period 2) | 3 |
| PF-06882961 Titration up to 120mg BID (Period 3) | 5 |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 2 |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 3 |
| PF-06882961 Titration up to 200mg BID (Period 6) | 5 |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 0 |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 9 |
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
"The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included little interest/pleasure in things, feeling down depressed or hopeless, trouble falling or staying asleep, feeling tired or little energy, poor appetite or overeating, feeling bad about yourself, trouble concentrating on things, moving slowly or fidgety/restless and thoughts you be better off dead. Each item was scored on scale of not at all, several days, more than half the days to nearly every day. Total score range: 0-27 (each item with scale from 0 [not at all] to 3 [nearly every day]. Higher score=greater severity)." (NCT04621227)
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
| Intervention | Participants (Count of Participants) |
|---|
| BL Little Interest/Pleasure in Things72022069 | BL Feeling Down Depressed or Hopeless72022069 | BL Trouble Falling or Staying Asleep72022069 | BL Feeling Tired or Little Energy72022069 | BL Poor Appetite or Overeating72022069 | BL Feeling Bad About Yourself72022069 | BL Trouble Concentrating on Things72022069 | BL Moving Slowly or Fidgety/Restless72022069 | BL Thoughts You Be Better Off Dead72022069 | Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless72022069 | Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless72022069 | Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless72022069 | Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless72022069 | Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless72022069 | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless72022069 | Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless72022069 | Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless72022069 | Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless72022069 | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead72022069 | Follow Up Little Interest/Pleasure in Things72022069 | Follow Up Feeling Down Depressed or Hopeless72022069 | Follow Up Trouble Falling or Staying Asleep72022069 | Follow Up Feeling Tired or Little Energy72022069 | Follow Up Poor Appetite or Overeating72022069 | Follow Up Feeling Bad About Yourself72022069 | Follow Up Trouble Concentrating on Things72022069 | Follow Up Moving Slowly or Fidgety/Restless72022069 | Follow Up Thoughts You Be Better Off Dead72022069 | ET Little Interest/Pleasure in Things72022069 | ET Feeling Down Depressed or Hopeless72022069 | ET Trouble Falling or Staying Asleep72022069 | ET Feeling Tired or Little Energy72022069 | ET Poor Appetite or Overeating72022069 | ET Feeling Bad About Yourself72022069 | ET Trouble Concentrating on Things72022069 | ET Moving Slowly or Fidgety/Restless72022069 | ET Thoughts You Be Better Off Dead72022069 |
|---|
| Not At All | Several Days | More Than Half The Days | Nearly Every Day |
|---|
| All Participants | 16 |
| All Participants | 11 |
| All Participants | 3 |
| All Participants | 13 |
| All Participants | 2 |
| All Participants | 12 |
| All Participants | 1 |
| All Participants | 14 |
| All Participants | 0 |
| All Participants | 15 |
Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration. (NCT04621227)
Timeframe: At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7
| Intervention | nanogram*hour per milliliter (ng*hr/mL) (Geometric Mean) |
|---|
| Rosuvastatin 10mg (Period 1) | 35.17 |
| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 72.15 |
| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 100.90 |
AUClast of Midazolam in Periods 2, 5 and 8
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration. (NCT04621227)
Timeframe: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8
| Intervention | nanogram*hour per milliliter (ng*hr/mL) (Geometric Mean) |
|---|
| Midazolam 2mg (Period 2) | 39.24 |
| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 19.98 |
| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 20.21 |
Change From Baseline in Body Weight
Changes from Baseline in body weight of the participants were measured. (NCT04621227)
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)
| Intervention | kilogram (kg) (Mean) |
|---|
| Period 3 Day 1 / PF-06882961 titration up to 120 mg BID | Period 3 Day 8 / PF-06882961 titration up to 120 mg BID | Period 3 Day 15 / PF-06882961 titration up to 120 mg BID | Period 3 Day 22 / PF-06882961 titration up to 120 mg BID | Period 4 Day 1 / PF-06882961 120 mg BID + rosuvastatin 10 mg | Period 6 Day 1 / PF-06882961 titration up to 200 mg BID | Period 6 Day 9 / PF-06882961 titration up to 200 mg BID | Period 7 Day 1 / PF-06882961 200 mg BID + rosuvastatin 10 mg | Period 8 Day 2 / PF-06882961 200 mg BID + midazolam 2 mg | Follow up |
|---|
| All Participants | -1.5 | -1.9 | -3.3 | -4.3 | -5.2 | -6.1 | -7.5 | -9.1 | -9.9 | -5.7 |
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments included pulse rate (PR), QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value >= 300msec, or BL >200msec and >=25% increase from BL, or BL <=200msec and >=50% increase from BL; QRS interval value >= 140msec, or percent change from BL >=50%; QTcF value >400 and <=480msec, or >480 and <=500 msec, or >500msec, or change from BL>30 and <=60msec, or change from BL >60msec. (NCT04621227)
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
| Intervention | Participants (Count of Participants) |
|---|
| PR interval value>=300 msec | PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase) | QRS interval value>=140 msec | QRS interval %change >=50% | QTcF value >450 and <=480 msec | QTcF value >480 and <=500 msec | QTcF value >500 msec | QTcF change >30 and <=60 msec | QTcF change >60 msec |
|---|
| Midazolam 2mg (Period 2) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| PF-06882961 Titration up to 120mg BID (Period 3) | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
,| PF-06882961 Titration up to 200mg BID (Period 6) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,| Rosuvastatin 10mg (Period 1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
"The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of yes on actual attempt), 3: preparatory acts towards imminent suicidal behavior (yes on aborted attempt, interrupted attempt, preparatory acts/behavior), 4: suicidal ideation (yes on wish to be dead, non-specific active suicidal thoughts), 7: self-injurious behavior, no suicidal intent (yes on has participant engaged in non-suicidal self-injurious behavior). In this outcome, number of participants with positive response (response of yes) to suicidal behavior, ideation, or any self-injurious behavior were reported." (NCT04621227)
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination
| Intervention | Participants (Count of Participants) |
|---|
| BL | BL (Past 12 months) | Period 3 Day 1 / PF-06882961 titration up to 120mg BID (Since last visit) | Period 3 Day 8 / PF-06882961 titration up to 120mg BID (Since last visit) | Period 3 Day 15 / PF-06882961 titration up to 120mg BID (Since last visit) | Period 3 Day 22 / PF-06882961 titration up to 120mg BID (Since last visit) | Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg (Since last visit) | Period 6 Day 1 / PF-06882961 titration up to 200mg BID (Since last visit) | Period 6 Day 9 / PF-06882961 titration up to 200mg BID (Since last visit) | Period 6 Day 16 / PF-06882961 titration up to 200mg BID (Since last visit) | Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg (Since last visit) | Follow Up (Since last visit) | Early Termination (ET) (Since last visit) |
|---|
| All Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. (NCT04621227)
Timeframe: From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
| Intervention | Participants (Count of Participants) |
|---|
| All-causality TEAEs | Treatment-related TEAEs |
|---|
| Midazolam 2mg (Period 2) | 2 | 0 |
,| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 5 | 5 |
,| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 6 | 5 |
,| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 8 | 7 |
,| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 7 | 3 |
,| PF-06882961 Titration up to 120mg BID (Period 3) | 13 | 11 |
,| PF-06882961 Titration up to 200mg BID (Period 6) | 11 | 10 |
,| Rosuvastatin 10mg (Period 1) | 0 | 0 |
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate <40 beats per minute (bpm) or >120bpm; supine diastolic BP <50 millimeter of mercury (mmHg), increase and decrease in change from BL of >=20mmHg; supine systolic blood pressure <90mmHg, increase and decrease in change from BL of >=30mmHg. (NCT04621227)
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)
| Intervention | Participants (Count of Participants) |
|---|
| Pulse rate value <40bpm | Pulse rate value >120bpm | Supine diastolic BP value <50mmHg | Supine diastolic BP change >=20mmHg increase | Supine diastolic BP change >=20mmHg decrease | Supine systolic BP value <90mmHg | Supine systolic BP change >=30mmHg increase | Supine systolic BP change >=30mmHg decrease |
|---|
| Midazolam 2mg (Period 2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| PF-06882961 120mg BID + Midazolam 2mg (Period 5) | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 2 |
,| PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,| PF-06882961 200mg BID + Midazolam 2mg (Period 8) | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
,| PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7) | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 |
,| PF-06882961 Titration up to 120mg BID (Period 3) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
,| PF-06882961 Titration up to 200mg BID (Period 6) | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 3 |
,| Rosuvastatin 10mg (Period 1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.
The primary objective of this study is to compare the LDL lowering of rosuvastatin with the effect of six commonly used dietary supplements on cholesterol health. (NCT04846231)
Timeframe: The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks
| Intervention | percent change LDL-C (Least Squares Mean) |
|---|
| Percent change from baseline | Difference in Percent Change |
|---|
| Cinnamon | 0.42 | 38.27 |
,| Fish Oil | -3.43 | 34.43 |
,| Garlique | 5.13 | 42.98 |
,| Placebo | -2.63 | 35.22 |
,| Plant Sterol | -4.37 | 33.49 |
,| Red Yeast Rice | -6.55 | 31.31 |
,| Rosuvastatin | -37.86 | 0 |
,| Turmeric | -1.29 | 36.57 |
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo. (NCT04846231)
Timeframe: After 4 weeks
| Intervention | % change HDLC, tot chole, triglycerides (Least Squares Mean) |
|---|
| Percent change from baseline HDL-C | Difference in percent change HDL-C | Percent change from baseline total cholesterol | Difference in percent change total cholesterol | Percent change from baseline triglycerides | Difference in percent change triglycerides |
|---|
| Cinnamon | -2.33 | -5.41 | 0.37 | 1.81 | 8.34 | 9.88 |
,| Fish Oil | 2.41 | -0.67 | -2.23 | -0.79 | -5.01 | -3.65 |
,| Garlique | 3.43 | 0.35 | 2.80 | 4.24 | -5.43 | -4.08 |
,| Placebo | 3.08 | 0 | -1.44 | 0 | -1.41 | 0 |
,| Plant Sterol | -4.02 | -7.09 | -3.89 | -2.45 | 1.28 | 2.73 |
,| Red Yeast Rice | 2.45 | -0.63 | -2.60 | -1.16 | 4.11 | 5.60 |
,| Rosuvastatin | 3.44 | 0.37 | -24.43 | -22.99 | -19.25 | -18.09 |
,| Turmeric | 1.42 | -1.66 | -0.75 | 0.69 | 0.26 | 1.69 |
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.
"The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin.~The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin. The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo." (NCT04846231)
Timeframe: After 4 weeks
| Intervention | % change HDLC,Tot Cholest, Triglycerides (Least Squares Mean) |
|---|
| Percent change from baseline HDL-C | Difference in percentage change HDL-C | Percent change from baseline Total Cholesterol | Difference in percent change Total Cholesterol | Percent change from baseline Triglycerides | Difference in percent change Triglycerides |
|---|
| Cinnamon | -2.33 | -5.78 | 0.37 | 24.80 | 8.34 | 34.16 |
,| Fish Oil | 2.41 | -1.03 | -2.23 | 22.20 | -5.01 | 17.64 |
,| Garlique | 3.43 | -0.02 | 2.80 | 27.23 | -5.43 | 17.11 |
,| Placebo | 3.08 | -0.37 | -1.44 | 22.99 | -1.41 | 22.09 |
,| Plant Sterol | -4.02 | -7.46 | -3.89 | 20.54 | 1.28 | 25.42 |
,| Red Yeast Rice | 2.45 | -0.99 | -2.60 | 21.83 | 4.11 | 28.93 |
,| Rosuvastatin | 3.44 | 0 | -24.43 | 0 | -19.25 | 0 |
,| Turmeric | 1.42 | -2.03 | -0.75 | 23.68 | 0.26 | 24.16 |
Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.
Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg. (NCT04846231)
Timeframe: The percent change in high sensitivity C reactive protein (hsCRP) for rosuvastatin 5 mg and dietary supplements compared with placebo after 4 weeks.
| Intervention | percent change hsCRP (Least Squares Mean) |
|---|
| percentage change from baseline | Difference in percent change |
|---|
| Cinnamon | 29.04 | 36.85 |
,| Fish Oil | -1.39 | 4.58 |
,| Garlique | 1.09 | 7.20 |
,| Placebo | -7.12 | -1.50 |
,| Plant Sterol | -13.72 | -8.50 |
,| Red Yeast Rice | 6.28 | 12.71 |
,| Rosuvastatin | -5.70 | 0 |
,| Turmeric | -4.49 | 1.29 |
AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin
The PK parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
| Intervention | h*ng/mL (Geometric Mean) |
|---|
| Rosuvastatin | 36.20 |
| Sotorasib + Rosuvastatin | 48.40 |
AUCinf of Sotorasib
The PK parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6
| Intervention | h*ng/mL (Geometric Mean) |
|---|
| Sotorasib + Rosuvastatin | 22900 |
AUClast of Sotorasib
The PK parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6
| Intervention | h*ng/mL (Geometric Mean) |
|---|
| Sotorasib + Rosuvastatin | 22500 |
Cmax of Sotorasib
The PK parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6
| Intervention | ng/mL (Geometric Mean) |
|---|
| Sotorasib + Rosuvastatin | 4650 |
Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin
The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
| Intervention | ng/mL (Geometric Mean) |
|---|
| Rosuvastatin | 3.80 |
| Sotorasib + Rosuvastatin | 6.47 |
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin
The PK parameters were determined using standard non-compartmental methods. (NCT05045638)
Timeframe: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
| Intervention | h*ng/mL (Geometric Mean) |
|---|
| Rosuvastatin | 33.20 |
| Sotorasib + Rosuvastatin | 44.50 |
Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs)
Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms (ECGs), and vital signs results were recorded as AEs. (NCT05045638)
Timeframe: Day 1 to Day 41
| Intervention | Participants (Count of Participants) |
|---|
| Rosuvastatin | 0 |
| Sotorasib + Rosuvastatin | 0 |