Comparative Atorvastatin Pleiotropic Effects (CAP)

Viatris

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia; Coronary Arteriosclerosis

Treatments: Procedure: Blood samples; Drug: Atorvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00163202

A2581065

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind