Condition category
Circulatory System
Date applied
11/02/2011
Date assigned
15/04/2011
Last edited
24/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22815989

Publication citations

  1. 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.

Additional files

Editorial Notes