NCT01004705

A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.

Conditions

• Elevated LDL Cholesterol

Interventions

Type	Name	Description
DRUG	Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),	A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
DRUG	Simvastatin	A once daily oral dose of simvastatin for 12 weeks.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-10-30
• Last updated: 2012-08-31
• Results posted: 2012-08-31

Locations

1 site across 1 country: United States