Comparative Atorvastatin Pleiotropic Effects

Phase 4

Completed

• Conditions: Hypercholesterolemia; Coronary Arteriosclerosis

• Registration Number: NCT00163202
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study Completion: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇰 Bratislava, Slovakia