Comparative Atorvastatin Pleiotropic Effects

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT00163202
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Comparative Atorvastatin Pleiotropic Effects CAP
• Scientific 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
• Date of first enrolment: June 2002
• Target sample size: 330
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00163202
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 4

Countries of recruitment

Canada, Czech Republic, Czechia, France, Poland, Romania, Russian Federation, Slovakia

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Arteriosclerosis

Hypercholesterolemia

Intervention(s)

Drug: Atorvastatin

Procedure: Blood samples

Primary Outcome(s)

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(s)

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

Secondary ID(s)

A2581065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bio-Inova Life Sciences International

MDS Pharma Services