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Comparative Atorvastatin Pleiotropic Effects (CAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163202
First Posted: September 13, 2005
Last Update Posted: March 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
MDS Pharma Services
Bio-Inova Life Sciences International
Information provided by:
Pfizer
September 9, 2005
September 13, 2005
March 18, 2008
June 2002
Not Provided
Percentages changes of the hs-CRP between baseline (means between week-2 to -1 and week 0 (V2) values) and week 26 (V5).
Same as current
Complete list of historical versions of study NCT00163202 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Comparative Atorvastatin Pleiotropic Effects
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Coronary Arteriosclerosis
  • Hypercholesterolemia
  • Procedure: Blood samples
  • Drug: Atorvastatin
Not Provided
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. doi: 10.1016/j.clinthera.2008.12.023.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
August 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   France,   Poland,   Romania,   Russian Federation,   Slovakia
 
 
NCT00163202
A2581065
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
  • MDS Pharma Services
  • Bio-Inova Life Sciences International
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP