PILL Pilot: Programme to Improve Life and Longevity
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Purpose:
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:
"Polypill"
Contains aspirin 75 mg, simvastatin 20 mg, lisinopril 10 mg and hydrochlorothiazide 12.5 mg.
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Placebo
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.
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Location(s):
India, New Zealand, Australia, Brazil, The Netherlands, United Kingdom and USA
Year Started:
2008
Year Finished:
2010
Design:
Randomised, placebo-controlled trial.
Inclusion Criteria
Persons at risk for cardiovascular disease but not on any preventive measures currently; no allergies to aspirin, simvastatin, lisinopril, or hydrochlorothiazide.
Exclusion Criteria
Allergies to aspirin, simvastatin, lisinopril, or hydrochlorothiazide.
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.
Primary Outcome:
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 Outcome:
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.
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Source of Information:
Clinical Trials Research Unit at Auckland
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Web Links and Publications:
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This information last updated on: 5/7/2010
Reviewed on: 05/07/2010.
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