drugset / Trial / NCT01362218

Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

NCT01362218

Phase 2 Terminated 107 enrolled Ferrer Internacional S.A.
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2010-10
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule Oral
Comparator Ramipril Small molecule Oral
Comparator Simvastatin Small molecule Oral