Page last updated: 2024-11-12

amlodipine, atorvastatin drug combination

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID11982821
MeSH IDM0548292

Synonyms (5)

Synonym
amlodipine, atorvastatin drug combination
amlodipine/atorvastatin
930274-47-8
DTXSID101009852
calcium;benzenesulfonic acid;3-o-ethyl 5-o-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate;(3r,5r)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"7%) patients due to adverse events."( EFFICACY AND SAFETY OF A SINGLE-PILL COMBINATION OF ATORVASTATIN/AMLODIPINE IN PATIENTS WITH ARTERIAL HYPERTENSION AND DYSLIPIDEMIA.
Georgieva Torbova-Gigova, S; Ivanov Manov, E; Margaritov Runev, N; Naydenov Naydenov, S, 2018
)
0.48

Bioavailability

ExcerptReferenceRelevance
" The bioavailability of amlodipine and atorvastatin with a single-tablet, fixed-dose amlodipine/atorvastatin combination was not significantly different to that with coadministered separate amlodipine and atorvastatin tablets."( Amlodipine/Atorvastatin: a review of its use in the treatment of hypertension and dyslipidaemia and the prevention of cardiovascular disease.
Curran, MP, 2010
)
0.36

Dosage Studied

ExcerptRelevanceReference
" The combination of amlodipine and atorvastatin in 8 different dosage strengths were flexibly titrated over a period of 14 weeks."( Impact of combination therapy with amlodipine and atorvastatin on plasma adiponectin levels in hypertensive patients with coronary artery disease: combination therapy and adiponectin.
Cheung, BM; Lam, KS; Li, M; Tse, HF; Xu, A, 2011
)
0.37
"BACKGROUND Is the timing of dosing for amlodipine and atorvastatin important with regard to therapeutic efficacy? To answer this question, we designed an outpatient, practice-based, case-control study lasting 8 weeks."( Is Time an Important Problem in Management of Hypertension and Hypercholesterolemia by Using an Amlodipine-Atorvastatin Single Pill Combination?
Wang, M; Zeng, R; Zhang, L, 2016
)
0.43
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (33)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's7 (21.21)29.6817
2010's24 (72.73)24.3611
2020's2 (6.06)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 35.30

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index35.30 (24.57)
Research Supply Index3.91 (2.92)
Research Growth Index4.79 (4.65)
Search Engine Demand Index45.90 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (35.30)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials14 (40.00%)5.53%
Reviews6 (17.14%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other15 (42.86%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (16)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 4304 participants (Anticipated)Interventional2019-03-01Not yet recruiting
Effect of Caduet and TLC Intervention on Metabolic Parameters [NCT03504735]Phase 453 participants (Actual)Interventional2005-05-01Completed
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 118 participants (Actual)Interventional2019-02-23Completed
Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan) [NCT01107743]1,291 participants (Actual)Observational2010-06-30Completed
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 4159 participants (Actual)Interventional2010-08-31Completed
Evaluation of Carotid Intima Media Thickness by Treatment of Vascular and Metabolic Factors With Combined Antihypertensive and Hypolipidemic Therapy [NCT04306627]Phase 4200 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE) [NCT00150384]Phase 4500 participants Interventional2004-07-31Completed
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 4220 participants Interventional2006-06-30Completed
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia [NCT00143234]Phase 31,825 participants Interventional2004-05-31Completed
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 31,250 participants Interventional2004-10-31Completed
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 4259 participants (Actual)Interventional2019-05-30Completed
Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation (IMPRESSION) [NCT04111419]Phase 41,200 participants (Anticipated)Interventional2020-07-01Recruiting
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 41,120 participants Interventional2004-10-31Completed
Blood Pressure and Lipids Reduction in High Risk Elderly Patients With Isolated Systolic Hypertension [NCT05165251]Phase 4480 participants (Anticipated)Interventional2022-01-04Recruiting
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment [NCT05398393]150 participants (Anticipated)Interventional2022-01-01Enrolling 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 132 participants (Actual)Interventional2017-05-07Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
NCT01107743 (38) [back to overview]Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
NCT01107743 (38) [back to overview]Number of Treatment Related Adverse Events.
NCT01107743 (38) [back to overview]Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
NCT01107743 (38) [back to overview]Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Age.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Complications.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Gender.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
NCT01107743 (38) [back to overview]Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
NCT01107743 (38) [back to overview]Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
NCT01190007 (12) [back to overview]Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
NCT01190007 (12) [back to overview]Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
NCT01190007 (12) [back to overview]Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
NCT01190007 (12) [back to overview]Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
NCT01190007 (12) [back to overview]Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
NCT01190007 (12) [back to overview]Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
NCT01190007 (12) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01190007 (12) [back to overview]Percent Change From Baseline in Apolipoprotein B at Each Visit
NCT01190007 (12) [back to overview]Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
NCT01190007 (12) [back to overview]Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
NCT01190007 (12) [back to overview]Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
NCT01190007 (12) [back to overview]Percent Change From Baseline in Triglyceride (TG) at Each Visit

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

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet163

[back to top]

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

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet1034

[back to top]

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

Interventionparticipants (Number)
Amlodipine and Atorvastatin Combination Tablet1151

[back to top] [back to top]

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

Interventionparticipants (Number)
Type Ⅰ13
Type Ⅱa533
Type Ⅱb180
Type Ⅲ10
Type Ⅳ5

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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

Interventionparticipants (Number)
<65 Years45
>=65 Years118

[back to top]

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

Interventionparticipants (Number)
Class1122
Class211
Class32
Class41

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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

Interventionparticipants (Number)
Without Complications57
With Complications106

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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

Interventionparticipants (Number)
Without Concomitant Drugs22
With Concomitant Drugs141

[back to top]

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

Interventionparticipants (Number)
Male75
Female88

[back to top]

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

Interventionparticipants (Number)
Without Hepatic Dysfunction145
With Hepatic Dysfunction18

[back to top]

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

Interventionparticipants (Number)
Without Renal Dysfunction137
With Renal Dysfunction25

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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

Interventionparticipants (Number)
<65 Years305
>=65 Years729

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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

Interventionparticipants (Number)
Without Complications482
With Complications552

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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

Interventionparticipants (Number)
Without Concomitant Drugs306
With Concomitant Drugs728

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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

Interventionparticipants (Number)
Male380
Female654

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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

Interventionparticipants (Number)
Without Hepatic Dysfunction904
With Hepatic Dysfunction122

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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

Interventionparticipants (Number)
Without Renal Dysfunction937
With Renal Dysfunction88

[back to top]

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

Interventionparticipants (Number)
<65 Years347
>=65 Years804

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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

Interventionparticipants (Number)
Without Complications527
With Complications624

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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

Interventionparticipants (Number)
Without Concomitant Drugs339
With Concomitant Drugs812

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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

Interventionparticipants (Number)
Male415
Female736

[back to top]

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

Interventionparticipants (Number)
Without Hepatic Dysfunction1008
With Hepatic Dysfunction131

[back to top]

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

Interventionparticipants (Number)
ClassⅠ615
ClassⅡ325
ClassⅢ85

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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

Interventionparticipants (Number)
Without Renal Dysfunction1036
With Renal Dysfunction102

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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

InterventionRatio (Mean)
Week 4 (n=157)Week 12 (n=155)Week 24 (n=151)Week 52 (n=144)Week 52 (LOCF) (n=156)
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

InterventionRatio (Mean)
Week 4 (n=157)Week 12 (n=156)Week 24 (n=151)Week 52 (n=145)Week 52 (LOCF) (n=157)
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

InterventionmmHg (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)
Caduet0.8-1.1-1.0-1.1-2.2-0.9-3.5-3.0-4.8-2.5-1.2-2.6-0.7-4.4-3.2

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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

InterventionmmHg (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)
Caduet0.3-0.40.2-0.2-0.7-1.8-1.6-2.6-3.5-4.3-3.2-2.5-2.0-0.6-0.6

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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

InterventionmmHg (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)
Caduet-0.2-0.60.0-0.4-1.5-2.8-1.8-3.1-4.8-4.8-4.4-4.0-2.3-1.5-1.5

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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

InterventionmmHg (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)
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

InterventionParticipants (Number)
AESAE
Caduet12011

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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

InterventionPercentage 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)
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

InterventionPercentage 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)
Caduet1.54.0-0.52.22.5

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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

InterventionPercentage 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)
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

InterventionPercentage of TC (Mean)
Week 4 (n=157)Week 12 (n=156)Week 24 (n=151)Week 52 (n=145)Week 52 (LOCF) (n=157)
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

InterventionPercentage of TG (Mean)
Week 4 (n=157)Week 12 (n=156)Week 24 (n=151)Week 52 (n=145)Week 52 (LOCF) (n=157)
Caduet8.23.66.48.57.2

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