Polypill Prevention Trial 1

ISRCTN	ISRCTN36672232
DOI	https://doi.org/10.1186/ISRCTN36672232
Secondary identifying numbers	PPT01

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

Study design	Randomised placebo-controlled double-blind cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	05/01/2011
Completion date	05/07/2013

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	50-100
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

Queen Mary University of London (UK)
University/education

Queen Mary Innovation Centre
5 Walden Street
Whitechapel
London
E1 2EF
England
United Kingdom

Email	gerry.leonard@bartsandthelondon.nhs.uk
"ROR"	https://ror.org/026zzn846

Charity

Barts and the London Charitable Foundation (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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