NCT01362218

Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 18 Years – 75 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 the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 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 8 weeks.
DRUG	Simvastatin, ramipril, acetylsalicylic acid	A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-05-30
• Last updated: 2013-04-24

Locations

1 site across 1 country: Spain