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Polypill Prevention Trial 1
ISRCTN ISRCTN36672232
DOI 10.1186/ISRCTN36672232
ClinicalTrials.gov identifier
EudraCT number
Public title Polypill Prevention Trial 1
Scientific title A randomised placebo controlled double-blind cross-over trial of the Polypill on risk factor reduction
Acronym PPT1
Serial number at source PPT01
Study hypothesis To determine the reduction in serum cholesterol and blood pressure using the polypill and to assess the prevalence of adverse effects
Lay summary Not provided at time of registration
Ethics approval North London Research Ethics Committee 1, approved on 29th September 2010, REC Ref: 10/HO717/66
Study design Randomised placebo-controlled double-blind cross-over trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cardiovascular Disease
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 05/01/2011
Anticipated end date 05/07/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 50-100
Interventions 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
Primary outcome measure(s) 1. Serum cholesterol
2. Systolic blood pressure
3. Diastolic blood pressure
Outcomes assessed at the end of each 12 week treatment period
Secondary outcome measure(s) 1. Adverse effects
2. Adherence
Sources of funding Barts and the London Charitable Foundation (UK)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22815989
Contact name Dr  David  Wald
  Address Wolfson Institute of Preventive Medicine
Chartehouse Square
  City/town London
  Zip/Postcode EC1M 6BQ
  Country United Kingdom
  Email d.s.wald@qmul.ac.uk
Sponsor Queen Mary University of London (UK)
  Address Queen Mary Innovation Centre
5 Walden Street
Whitechapel
  City/town London
  Zip/Postcode E1 2EF
  Country United Kingdom
  Email gerry.leonard@bartsandthelondon.nhs.uk
Date applied 11/02/2011
Last edited 24/09/2012
Date ISRCTN assigned 15/04/2011
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