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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001378
ACTR Number: ACTRN12607000099426
Trial Status: Registered
Date Submitted: 4/10/2006
Date Registered: 30/01/2007

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Public title: Programme to Improve Life and Longevity Pilot
ANZCTR registration title: Is a polypill tolerable and effective at improving blood pressure and cholesterol control in people at raised risk of cardiovascular disease
Secondary ID: 
UTN:
Trial acronym: PILL Pilot

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Health condition(s) or problem(s) studied:
Raised risk of cardiovascular disease 
Condition category: Condition code:
Cardiovascular Diseases of the vasculature and circulation including the lymphatic system 

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Description 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.
Intervention code:Prevention 
Comparator / control treatment: Placebo - one tablet once a day, for 12 weeks.
Control group: Placebo

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Primary outcome 1:Change in systolic blood pressure. 
Timepoint:Measured at baseline and then at the end of the study (12 weeks). 
Primary outcome 2:Change in Low-Density Lipoprotein (LDL)-cholesterol. 
Timepoint:Measured at baseline and then at the end of the study (12 weeks). 
Primary outcome 3:Tolerability (the proportion who withdraw from study treatment). 
Timepoint:During the study. 
Secondary outcome 1:1. Adherence to study medication 
Timepoint:At study end (12 weeks) 
Secondary outcome 2:2. Change in diastolic blood pressure 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 3:3. Change in total cholesterol 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 4:4. Change in High-Density Lipoprotein (HDL)-cholesterol 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 5:5. Change in non-HDL cholesterol 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 6:6. Change in triglycerides 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 7:7. Frequency of switching to open-label treatment 
Timepoint:During the study 
Secondary outcome 8:8. Change in cardiovascular disease (CVD) risk (Framingham) 
Timepoint:Measured at baseline and then at the end of the study (12 weeks) 
Secondary outcome 9:9. Frequency of serious adverse events 
Timepoint:During the study 
Secondary outcome 10:10. Frequency of adverse events 
Timepoint:During the study 

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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
Minimum Age: 18 Years
Maximum Age: Not stated
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: exclusion criteria:1. Life-limiting disease or events

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
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.
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.
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people receiving the treatment/s
 The people administering the treatment/s
 The people assessing the outcomes
 The people analysing the results/data
Assignment: Parallel
Other design features (specify): 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.
Type of endpoint(s): Efficacy

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Phase Phase 3
Anticipated or actual date of first participant enrolement: 17/10/2008
Target sample size: 400
Recruitment status: Open to recruitment

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Funding source 1:Government funding body e.g. Australian Research Council 
Name:Health Research Council of New Zealand (International Investment Opportunities Fund) 
Address:PO Box 5541, Wellesley Street, Auckland 
Country:New Zealand 
Funding source 2:Charities/Societies/Foundations 
Name:National Heart Foundation of New Zealand (Research Fellowship) 
Address:P O Box 17-160, Greenlane , Auckland 
Country:New Zealand 
Funding source 3:Commercial sector/Industry 
Name:Dr Reddy's Laboratories Limited 
Address:7-1-27 Ameerpet, Hyderabad 500 016, Andra Pradesh 
Country:India 
Primary sponsor: Government funding body e.g. Department of Health
Name: Health Research Council of New Zealand
Address: PO Box 5541, Wellesley Street, Auckland
Country: New Zealand
Secondary sponsor:None 
Name:NA 
Address:NA 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Northern Y Regional Ethics committee 
Address:Ministry of Health, PO Box 1031, Hamilton 
Country:New Zealand 
Date of approval:23/05/2007 
HREC Number:NTY/06/11/111 
Countries of recruitment:Australia 
Postcode:2050 
Outside Australia 
New Zealand 
India 
Brazil 
United Kingdom 
United States of America 
Netherlands 
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.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Angela Wadham
Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country: New Zealand
Tel: +64 9 3737999
Fax: +64 9 3731710
Email: pill@ctru.auckland.ac.nz

Contact person for scientific queries
Name: Anthony Rodgers
Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country: New Zealand
Tel: +61296570375
Fax: +64 9 3731710
Email: pill@ctru.auckland.ac.nz

Contact person responsible for updating information
Name: Angela Wadham
Address: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country: New Zealand
Tel: +64 9 3737999
Fax: +64 9 3731710
Email: regtrials@ctru.auckland.ac.nz
   
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