Comparative Atorvastatin Pleiotropic Effects - Full Text View

Comparative Atorvastatin Pleiotropic Effects (CAP)

This study has been completed.

First Received on September 9, 2005. Last Updated on March 14, 2008 History of Changes

Sponsor:	Pfizer
Collaborators:	MDS Pharma Services Bio-Inova Life Sciences International
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00163202

Purpose

The primary objective of the study is to evaluate the efficacy of atorvastatin 80 mg daily as compared to atorvastatin 10 mg daily in reducing C-reactive protein levels over a 26-week treatment period in subjects with documented coronary artery disease.

Condition	Intervention	Phase
Coronary Arteriosclerosis Hypercholesterolemia	Procedure: Blood samples Drug: Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized Double-Blind Study Comparing The Pleiotropic Effects Of Atorvastatin 10 Mg And 80 Mg Over A 26-Week Period In Subjects With Coronary Atherosclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).

Secondary Outcome Measures:

1/ the percentage change at visit 3 (5-week treatment), visit 4 (13-week-treatment) and visit 5 (26-week treatment) from baseline value in triglycerides, total cholesterol; HDL-cholesterol, LDL-cholesterol, apolipoprotein B 2/ the percentage change at

Estimated Enrollment:	330
Study Start Date:	June 2002
Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects of age of majority to < 80 years
Subjects with LDL-C > 0.5 g/L (1.29 mmol/L) and < 1.5 g/L (3.87 mmol/L), TG < 4.00 g/L (4.56 mmol/L) and hs-CRP >1.5 mg/L and < 15 mg/L
Subjects with a documented coronary artery disease.

Exclusion Criteria:

Female subjects of childbearing potential without contraception
Subjects with secondary hyperlipidemia
Diabetic subjects receiving insulin
Subjects with a contra-indication to statin therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163202

Show 74 Study Locations

Sponsors and Collaborators

Pfizer

MDS Pharma Services

Bio-Inova Life Sciences International

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bonnet J, McPherson R, Tedgui A, Simoneau D, Nozza A, Martineau P, Davignon J; CAP Investigators. Comparative effects of 10-mg versus 80-mg Atorvastatin on high-sensitivity C-reactive protein in patients with stable coronary artery disease: results of the CAP (Comparative Atorvastatin Pleiotropic effects) study. Clin Ther. 2008 Dec;30(12):2298-313.

ClinicalTrials.gov Identifier:	NCT00163202 History of Changes
Other Study ID Numbers:	A2581065
Study First Received:	September 9, 2005
Last Updated:	March 14, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012