drugset / Trial / NCT02791958

Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy

NCT02791958

Phase 2 Unknown 528 enrolled Ferrer Internacional S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.

Timeline

Start
2016-03
Primary completion
2017-10
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg Oral
Comparator Atorvastatin Small molecule 40 mg Oral
Comparator Ramipril Small molecule 10 mg Oral

Indications