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ISRCTN
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ISRCTN36672232
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DOI
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10.1186/ISRCTN36672232
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Polypill Prevention Trial 1
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Scientific title
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A randomised placebo controlled double-blind cross-over trial of the Polypill on risk factor reduction
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Acronym
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PPT1
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Serial number at source
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PPT01
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Study hypothesis
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To determine the reduction in serum cholesterol and blood pressure using the polypill and to assess the prevalence of adverse effects
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Lay summary
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Not provided at time of registration
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Ethics approval
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North London Research Ethics Committee 1, approved on 29th September 2010, REC Ref: 10/HO717/66
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Study design
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Randomised placebo-controlled double-blind cross-over trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular Disease
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Participants - inclusion criteria
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Men and women aged 50 and over, without selection on the basis of other risk factors, for whom there is no medical contra-indication to taking the Polypill
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Participants - exclusion criteria
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1. Clinical history of cardiovascular disease
2. Any illness judged to contra-indicate participation in the trial
3. Taking other specified drugs: lithium, cyclosporine or other calcineurin inhibitors, erythromycin or other macrolides, azole antifungals, ritonavir or other protease inhibitors, amiodarone
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Anticipated start date
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05/01/2011
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Anticipated end date
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05/07/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50-100
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Interventions
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Polypill (containing simvastatin, losartan, amlodipine and hydrochlorothiazide) - Each treatment arm lasts 12 weeks and consists of polypill or placebo in random order, followed by a 2 year open label monitoring phase
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Primary outcome measure(s)
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1. Serum cholesterol
2. Systolic blood pressure
3. Diastolic blood pressure
Outcomes assessed at the end of each 12 week treatment period
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Secondary outcome measure(s)
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1. Adverse effects
2. Adherence
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Sources of funding
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Barts and the London Charitable Foundation (UK)
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22815989
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Contact name
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Dr
David
Wald
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Address
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Wolfson Institute of Preventive Medicine
Chartehouse Square
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City/town
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London
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Zip/Postcode
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EC1M 6BQ
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Country
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United Kingdom
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Email
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d.s.wald@qmul.ac.uk
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Sponsor
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Queen Mary University of London (UK)
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Address
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Queen Mary Innovation Centre
5 Walden Street
Whitechapel
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City/town
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London
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Zip/Postcode
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E1 2EF
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Country
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United Kingdom
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Email
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gerry.leonard@bartsandthelondon.nhs.uk
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Date applied
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11/02/2011
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Last edited
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24/09/2012
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Date ISRCTN assigned
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15/04/2011
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