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Comparative Atorvastatin Pleiotropic Effects (CAP)

This study has been completed.
Sponsor:
Collaborators:
MDS Pharma Services
Bio-Inova Life Sciences International
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163202
First received: September 9, 2005
Last updated: March 14, 2008
Last verified: April 2007
History of Changes
  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 4

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:

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):

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 23, 2013