PILL Pilot: Programme to Improve Life and Longevity

Completed

Phase N/A Results N/A

Trial Description

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.

Interventions

  • Placebo Drug
    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.

Trial Design

Randomised, placebo-controlled trial.

Patient Involvement

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.

Outcomes

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.

Sponsors

Wellcome Trust British Heart Foundation Health Research Council of New Zealand The National Heart Foundation of New Zealand National Health & Medical Research Council Dr Reddy's Laboratories Limited