drugset / Trial / NCT01004705
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
RandomizedCrossoverOpen-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 simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | Oral |
| Subject | Ramipril | Small molecule | 5 mg | Oral |
| Subject | Ramipril | Small molecule | 10 mg | Oral |
| Comparator | Simvastatin | Small molecule | 40 mg | Oral |