Comparative Atorvastatin Pleiotropic Effects

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Bio-Inova Life Sciences International; MDS Pharma Services
• Treatments: Atorvastatin; Atorvastatin Calcium

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.