To assess the efficacy and tolerability of the polypill and provide preparatory data for a large clinical endpoint trial of the polypill in people at raised cardiovascular risk.
- Placebo Biological
Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
- "Polypill" (Dr. Reddings Red heart pill)Drug
Intervention Desc: Contains aspirin 75 mg, simvastatin 20 mg, lisinopril 10 mg and hydrochlorothiazide 12.5 mg.
Randomised, placebo-controlled trial.
Participants will be randomized to receive either Dr. Reddy’s Laboratories polypill or placebo for 12 weeks. Will have blood work and blood pressure readings to monitor response to treatment baseline and at 12 weeks.
|Type||Measure||Time Frame||Safety Issue|
|Primary||To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.|
|Secondary||Secondary aims are to measure adherence, the change in diastolic blood pressure, total cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, frequency of switching to open-label treatment, change in CVD risk, and adverse events.|