Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension [NCT03860220] | Phase 4 | 304 participants (Anticipated) | Interventional | 2019-03-01 | Not yet recruiting |
Effect of Caduet and TLC Intervention on Metabolic Parameters [NCT03504735] | Phase 4 | 53 participants (Actual) | Interventional | 2005-05-01 | Completed |
Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Ramipril, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration [NCT04262765] | Phase 1 | 18 participants (Actual) | Interventional | 2019-02-23 | Completed |
Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan) [NCT01107743] | | 1,291 participants (Actual) | Observational | 2010-06-30 | Completed |
A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia [NCT01190007] | Phase 4 | 159 participants (Actual) | Interventional | 2010-08-31 | Completed |
Evaluation of Carotid Intima Media Thickness by Treatment of Vascular and Metabolic Factors With Combined Antihypertensive and Hypolipidemic Therapy [NCT04306627] | Phase 4 | 200 participants (Anticipated) | Interventional | 2020-04-15 | Not yet recruiting |
Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE) [NCT00150384] | Phase 4 | 500 participants | Interventional | 2004-07-31 | Completed |
An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untrea [NCT00332761] | Phase 4 | 220 participants | Interventional | 2006-06-30 | Completed |
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia [NCT00143234] | Phase 3 | 1,825 participants | Interventional | 2004-05-31 | Completed |
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine -Atorvastatin Combination In Subjects With Hypertension and Dyslipidaemia. (The JEWEL Study) [NCT00330785] | Phase 3 | 1,250 participants | Interventional | 2004-10-31 | Completed |
Randomized, Multicenter, Parallel, Open, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension Patient With Dyslipidemia [NCT03951207] | Phase 4 | 259 participants (Actual) | Interventional | 2019-05-30 | Completed |
Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION) [NCT04111419] | Phase 4 | 1,200 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia. (The JEWEL II Study) [NCT00174304] | Phase 4 | 1,120 participants | Interventional | 2004-10-31 | Completed |
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension [NCT05165251] | Phase 4 | 480 participants (Anticipated) | Interventional | 2022-01-04 | Recruiting |
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment [NCT05398393] | | 150 participants (Anticipated) | Interventional | 2022-01-01 | Enrolling by invitation |
An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers [NCT03461081] | Phase 1 | 32 participants (Actual) | Interventional | 2017-05-07 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Amlodipine and Atorvastatin Combination Tablet | 163 |
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Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Amlodipine and Atorvastatin Combination Tablet | 1034 |
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Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Amlodipine and Atorvastatin Combination Tablet | 1151 |
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Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases." (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Type Ⅰ | 13 |
Type Ⅱa | 533 |
Type Ⅱb | 180 |
Type Ⅲ | 10 |
Type Ⅳ | 5 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
<65 Years | 45 |
>=65 Years | 118 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina." (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Class1 | 122 |
Class2 | 11 |
Class3 | 2 |
Class4 | 1 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Complications | 57 |
With Complications | 106 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Concomitant Drugs | 22 |
With Concomitant Drugs | 141 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Male | 75 |
Female | 88 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Hepatic Dysfunction | 145 |
With Hepatic Dysfunction | 18 |
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Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Renal Dysfunction | 137 |
With Renal Dysfunction | 25 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
<65 Years | 305 |
>=65 Years | 729 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Complications | 482 |
With Complications | 552 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Concomitant Drugs | 306 |
With Concomitant Drugs | 728 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Male | 380 |
Female | 654 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Hepatic Dysfunction | 904 |
With Hepatic Dysfunction | 122 |
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Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Renal Dysfunction | 937 |
With Renal Dysfunction | 88 |
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Risk Factors for the Proportion of Responders for Hypertension -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
<65 Years | 347 |
>=65 Years | 804 |
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Risk Factors for the Proportion of Responders for Hypertension -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Complications | 527 |
With Complications | 624 |
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Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Without Concomitant Drugs | 339 |
With Concomitant Drugs | 812 |
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Risk Factors for the Proportion of Responders for Hypertension -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
Male | 415 |
Female | 736 |
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Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
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Without Hepatic Dysfunction | 1008 |
With Hepatic Dysfunction | 131 |
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Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)." (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
---|
ClassⅠ | 615 |
ClassⅡ | 325 |
ClassⅢ | 85 |
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Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension. (NCT01107743)
Timeframe: 8 weeks
Intervention | participants (Number) |
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Without Renal Dysfunction | 1036 |
With Renal Dysfunction | 102 |
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Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 4, 12, 24, and 52
Intervention | Ratio (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=155) | Week 24 (n=151) | Week 52 (n=144) | Week 52 (LOCF) (n=156) |
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Caduet | -0.4 | -0.3 | -0.3 | -0.4 | -0.4 |
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Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 4, 12, 24, and 52
Intervention | Ratio (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=156) | Week 24 (n=151) | Week 52 (n=145) | Week 52 (LOCF) (n=157) |
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Caduet | -0.4 | -0.4 | -0.3 | -0.4 | -0.4 |
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Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mmHg (Mean) |
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| Week 2 (n=15) | Week 4 (n=16) | Week 8 (n=16) | Week 12 (n=16) | Week 16 (n=16) | Week 20 (n=16) | Week 24 (n=16) | Week 28 (n=16) | Week 32 (n=16) | Week 36 (n=15) | Week 40 (n=15) | Week 44 (n=15) | Week 48 (n=15) | Week 52 (n=15) | Week 52 (LOCF) (n=16) |
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Caduet | 0.8 | -1.1 | -1.0 | -1.1 | -2.2 | -0.9 | -3.5 | -3.0 | -4.8 | -2.5 | -1.2 | -2.6 | -0.7 | -4.4 | -3.2 |
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Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mmHg (Mean) |
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| Week 2 (n=140) | Week 4 (n=139) | Week 8 (n=140) | Week 12 (n=140) | Week 16 (n=138) | Week 20 (n=136) | Week 24 (n=134) | Week 28 (n=132) | Week 32 (n=132) | Week 36 (n=132) | Week 40 (n=132) | Week 44 (n=130) | Week 48 (n=130) | Week 52 (n=129) | Week 52 (LOCF) (n=142) |
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Caduet | 0.3 | -0.4 | 0.2 | -0.2 | -0.7 | -1.8 | -1.6 | -2.6 | -3.5 | -4.3 | -3.2 | -2.5 | -2.0 | -0.6 | -0.6 |
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Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mmHg (Mean) |
---|
| Week 2 (n=140) | Week 4 (n=139) | Week 8 (n=140) | Week 12 (n=140) | Week 16 (n=138) | Week 20 (n=136) | Week 24 (n=134) | Week 28 (n=132) | Week 32 (n=132) | Week 36 (n=132) | Week 40 (n=132) | Week 44 (n=130) | Week 48 (n=130) | Week 52 (n=129) | Week 52 (LOCF) (n=142) |
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Caduet | -0.2 | -0.6 | 0.0 | -0.4 | -1.5 | -2.8 | -1.8 | -3.1 | -4.8 | -4.8 | -4.4 | -4.0 | -2.3 | -1.5 | -1.5 |
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Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline (NCT01190007)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mmHg (Mean) |
---|
| Week 2 (n=15) | Week 4 (n=16) | Week 8 (n=16) | Week 12 (n=16) | Week 16 (n=16) | Week 20 (n=16) | Week 24 (n=16) | Week 28 (n=16) | Week 32 (n=16) | Week 36 (n=15) | Week 40 (n=15) | Week 44 (n=15) | Week 48 (n=15) | Week 52 (n=15) | Week 52 (LOCF) (n=16) |
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Caduet | -1.1 | -2.3 | -1.1 | -2.2 | -2.3 | -2.3 | -6.7 | -6.8 | -7.8 | -5.7 | -2.7 | -3.7 | -0.4 | -4.4 | -3.1 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. (NCT01190007)
Timeframe: 52 weeks
Intervention | Participants (Number) |
---|
| AE | SAE |
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Caduet | 120 | 11 |
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Percent Change From Baseline in Apolipoprotein B at Each Visit
"Value at each visits minus value at baseline divided by value at baseline multiplied by 100" (NCT01190007)
Timeframe: Week 4, 12, 24, and 52
Intervention | Percentage of Apolipoprotein B (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=156) | Week 24 (n=151) | Week 52 (n=145) | Week 52 (LOCF) (n=157) |
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Caduet | -9.2 | -5.8 | -7.4 | -9.1 | -9.3 |
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Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
"Value at each visits minus value at baseline divided by value at baseline multiplied by 100" (NCT01190007)
Timeframe: Weeks 4, 12, 24, and 52
Intervention | Percentage of HDL-C (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=156) | Week 24 (n=151) | Week 52 (n=145) | Week 52 (LOCF) (n=157) |
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Caduet | 1.5 | 4.0 | -0.5 | 2.2 | 2.5 |
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Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
"Value at each visits minus value at baseline divided by value at baseline multiplied by 100" (NCT01190007)
Timeframe: Weeks 4, 12, 24, and 52
Intervention | Percentage of LDL-C (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=155) | Week 24 (n=151) | Week 52 (n=144) | Week 52 (LOCF) (n=156) |
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Caduet | -10.9 | -7.4 | -10.5 | -12.3 | -12.2 |
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Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
"Value at each visits minus value at baseline divided by value at baseline multiplied by 100" (NCT01190007)
Timeframe: Weeks 4, 12, 24, and 52
Intervention | Percentage of TC (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=156) | Week 24 (n=151) | Week 52 (n=145) | Week 52 (LOCF) (n=157) |
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Caduet | -7.3 | -5.0 | -7.9 | -8.0 | -8.1 |
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Percent Change From Baseline in Triglyceride (TG) at Each Visit
"Value at each visits minus value at baseline divided by value at baseline multiplied by 100" (NCT01190007)
Timeframe: Week 4, 12, 24, and 52
Intervention | Percentage of TG (Mean) |
---|
| Week 4 (n=157) | Week 12 (n=156) | Week 24 (n=151) | Week 52 (n=145) | Week 52 (LOCF) (n=157) |
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Caduet | 8.2 | 3.6 | 6.4 | 8.5 | 7.2 |
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