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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | Oral |
| Comparator | Atorvastatin | Small molecule | 40 mg | Oral |
| Comparator | Ramipril | Small molecule | 10 mg | Oral |