Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferrer Internacional S.A.
• Treatments: Aspirin; Ramipril; Simvastatin

Criteria

Inclusion Criteria:

• Male or female subjects aged ≥18 and <75 years.

• Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.

• LDL-cholesterol ≥130 and ≤220 mg/dL.

• Systolic blood pressure ≥120 and <160 mmHg and diastolic blood pressure ≥70 and <100 mmHg.

• Provide written informed consent.

Exclusion Criteria: