Trial from ANZCTR


Trial ID ACTRN12607000099426
Trial Status: Registered
Date Submitted: 4/10/2006
Date Registered: 30/01/2007
Prospectively registered

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Public title Programme to Improve Life and Longevity Pilot
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Is a polypill tolerable and effective at improving blood pressure and cholesterol control in people at raised risk of cardiovascular disease
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Secondary ID [1] 273460 0
nil
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UTN
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Trial acronym PILL Pilot
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Health condition(s) or problem(s) studied:
Raised risk of cardiovascular disease 1594 0
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Condition category: Condition code:
Cardiovascular Diseases of the vasculature and circulation including the lymphatic system
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1697 1697 0 0

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Descriptions of intervention(s) / exposure Polypill - one tablet once a day for 12 weeks.
Polypill contains aspirin 75mg, simvastatin 20mg, lisinopril 10mg and hydrochlorothiazide 12.5mg.
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Intervention Code:
Prevention 1128 0
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Comparator / control treatment Placebo - one tablet once a day, for 12 weeks.
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Control group Placebo
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Primary Outcome: Change in systolic blood pressure. 2351 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks). 2351 0
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Primary Outcome: Change in Low-Density Lipoprotein (LDL)-cholesterol. 2352 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks). 2352 0
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Primary Outcome: Tolerability (the proportion who withdraw from study treatment). 2353 0
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Timepoint: During the study. 2353 0
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Secondary Outcome: 1. Adherence to study medication 4097 0
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Timepoint: At study end (12 weeks) 4097 0
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Secondary Outcome: 2. Change in diastolic blood pressure 4098 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4098 0
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Secondary Outcome: 3. Change in total cholesterol 4099 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4099 0
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Secondary Outcome: 4. Change in High-Density Lipoprotein (HDL)-cholesterol 4100 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4100 0
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Secondary Outcome: 5. Change in non-HDL cholesterol 4101 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4101 0
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Secondary Outcome: 6. Change in triglycerides 4102 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4102 0
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Secondary Outcome: 7. Frequency of switching to open-label treatment 4103 0
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Timepoint: During the study 4103 0
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Secondary Outcome: 8. Change in cardiovascular disease (CVD) risk (Framingham) 4104 0
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Timepoint: Measured at baseline and then at the end of the study (12 weeks) 4104 0
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Secondary Outcome: 9. Frequency of serious adverse events 4105 0
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Timepoint: During the study 4105 0
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Secondary Outcome: 10. Frequency of adverse events 4106 0
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Timepoint: During the study 4106 0
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Key inclusion criteria 1. Adults with 5-year cardiovascular risk of at least 7.5%. 2. No definite indication or contraindication for treatment with low dose aspirin, Angiotensin-Converting Enzyme (ACE) inhibitor, low-dose diuretic or statin. 3. Participant able to give informed consent
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Minimum age 18 Years
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Maximum age Not stated
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria exclusion criteria:1. Life-limiting disease or events
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) The participants will be randomised by a central computerized randomization program.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) A computerised randomisation program will be used to generate the random allocation sequence. A minimisation algorithm will include age, sex and centre. Individuals will be randomised to the polypill or matching placebo in a 1:1 ratio with a two group parallel trial design.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features Participants and investigators (clinicians, outcome assessors and data analysts) will be blinded to study medication allocation. During the review of the results within the study team, all investigators (clinicians, outcome assessors and data analysts) will be blinded to treatment allocation (all results will be presented as treatment A and B). The results will be unblinded once the final statistical report has been completed.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 17/10/2008
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 400
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2050 232 0
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Recruitment outside Australia

Country: New Zealand 331 0
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State/Province: 331 0
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Country: India 332 0
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State/Province: 332 0
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Country: Brazil 333 0
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State/Province: 333 0
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Country: United Kingdom 334 0
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State/Province: 334 0
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Country: United States of America 335 0
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State/Province: 335 0
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Country: Netherlands 336 0
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State/Province: 336 0
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Funding Source: Government body 1838 0
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Name: Health Research Council of New Zealand (International Investment Opportunities Fund) 1838 0
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Address: PO Box 5541, Wellesley Street, Auckland 1838 0
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Country: New Zealand 1838 0
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Funding Source: Charities/Societies/Foundations 1839 0
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Name: National Heart Foundation of New Zealand (Research Fellowship) 1839 0
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Address: P O Box 17-160, Greenlane , Auckland 1839 0
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Country: New Zealand 1839 0
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Funding Source: Commercial sector/Industry 1840 0
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Name: Dr Reddy's Laboratories Limited 1840 0
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Address: 7-1-27 Ameerpet, Hyderabad 500 016, Andra Pradesh 1840 0
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Country: India 1840 0
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Primary Sponsor Government body
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Name: Health Research Council of New Zealand
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Address: PO Box 5541, Wellesley Street, Auckland
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Country: New Zealand
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Secondary Sponsor: None 1658 0
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Name: NA 1658 0
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Address: NA 1658 0
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Country: 1658 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Northern Y Regional Ethics committee 3437 0
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Address: Ministry of Health, PO Box 1031, Hamilton 3437 0
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Country: New Zealand 3437 0
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Approval Date: 23/05/2007 3437 0
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Submitted Date: 3437 0
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HREC: NTY/06/11/111 3437 0
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Brief summary Cardiovascular disease (CVD) is the leading cause of hospitalisation and premature death in many countries globally. One of the most hotly debated issues in clinical research is whether a “polypill” (a new combination medication containing aspirin and agents to lower blood pressure and cholesterol) can really reduce cardiovascular disease by three-quarters or more. This clinical trial will assess the safety and tolerability of a polypill, and its effects on blood pressure and cholesterol in people at increased risk of CVD.
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Trial website
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Trial related presentations / publications An International Randomised Placebo-controlled Trial of a Four-component Combination Pill ("Polypill") in People of Raised Cardiovascular Risk. PILL Collaborative Group. Plos One: May 2011, volume 6, Issue 5, e19857.
www.plosone.org
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Angela Wadham
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Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country: New Zealand
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Tel: +64 9 3737999
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Fax: +64 9 3731710
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Email: pill@ctru.auckland.ac.nz
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Contact person for scientific queries
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Name: Anthony Rodgers
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Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country: New Zealand
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Tel: +61296570375
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Email: pill@ctru.auckland.ac.nz
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Contact person responsible for updating information
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Name: Angela Wadham
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Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country: New Zealand
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Tel: +64 9 3737999
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Fax: +64 9 3731710
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Email: regtrials@ctru.auckland.ac.nz
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Addition Cancer fields
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