Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Elevated LDL Cholesterol Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elevated LDL Cholesterol

• NCT number: NCT01362218
• Study type: Interventional
• Source: Ferrer Internacional S.A.
• Status: Terminated
• Phase: Phase 2
• Start date: October 2010
• Completion date: April 2012