Contact information
Type
Scientific
Primary contact
Dr David Wald
ORCID ID
Contact details
Wolfson Institute of Preventive Medicine
Chartehouse Square
London
EC1M 6BQ
United Kingdom
d.s.wald@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PPT01
Study information
Scientific title
A randomised placebo controlled double-blind cross-over trial of the Polypill on risk factor reduction
Acronym
PPT1
Study hypothesis
To determine the reduction in serum cholesterol and blood pressure using the polypill and to assess the prevalence of adverse effects
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular Disease
Intervention
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
Intervention type
Drug
Phase
Phase III
Drug names
Simvastatin, losartan, amlodipine, hydrochlorothiazide
Primary outcome measure
1. Serum cholesterol
2. Systolic blood pressure
3. Diastolic blood pressure
Outcomes assessed at the end of each 12 week treatment period
Secondary outcome measures
1. Adverse effects
2. Adherence
Overall trial start date
05/01/2011
Overall trial end date
05/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
50-100
Participant 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
Recruitment start date
05/01/2011
Recruitment end date
05/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Queen Mary Innovation Centre
5 Walden Street
Whitechapel
London
E1 2EF
United Kingdom
gerry.leonard@bartsandthelondon.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Barts and the London Charitable Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22815989
Publication citations
-
Results
Wald DS, Morris JK, Wald NJ, Randomized Polypill crossover trial in people aged 50 and over., PLoS ONE, 2012, 7, 7, e41297, doi: 10.1371/journal.pone.0041297.