drugset / Trial / NCT00567307
Polypill For Prevention of Cardiovascular Disease
Phase 2
Completed
216 enrolled
Wake Forest University Health Sciences
National Hospital of Sri Lanka · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-12
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 75 mg | — |
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | — |
| Subject | LISINOPRIL ANHYDROUS | Small molecule | 10 mg | — |
| Subject | Simvastatin | Small molecule | 20 mg | — |