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
  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:


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 April 16, 2014