Polypill Prevention Trial 1

ISRCTN	ISRCTN36672232
DOI	https://doi.org/10.1186/ISRCTN36672232
Protocol serial number	PPT01
Sponsor	Queen Mary University of London (UK)
Funder	Barts and the London Charitable Foundation (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Wald
Scientific

Wolfson Institute of Preventive Medicine
Chartehouse Square
London
EC1M 6BQ
United Kingdom

Email	d.s.wald@qmul.ac.uk

Primary study design	Interventional
Study design	Randomised placebo-controlled double-blind cross-over trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised placebo controlled double-blind cross-over trial of the Polypill on risk factor reduction
Study acronym	PPT1
Study objectives	To determine the reduction in serum cholesterol and blood pressure using the polypill and to assess the prevalence of adverse effects
Ethics approval(s)	North London Research Ethics Committee 1, approved on 29th September 2010, REC Ref: 10/HO717/66
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Simvastatin, losartan, amlodipine, hydrochlorothiazide
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
Key secondary outcome measure(s)	1. Adverse effects 2. Adherence
Completion date	05/07/2013

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	05/01/2011
Date of final enrolment	05/07/2013

Wolfson Institute of Preventive Medicine

London
EC1M 6BQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes