Trial registered on ANZCTR


Trial ID
ACTRN12607000099426
Ethics application status
Approved
Date submitted
4/10/2006
Date registered
30/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Programme to Improve Life and Longevity Pilot
Scientific title
Is a polypill tolerable and effective at improving blood pressure and cholesterol control in people at raised risk of cardiovascular disease
Secondary ID [1] 273460 0
nil
Universal Trial Number (UTN)
Trial acronym
PILL Pilot

Health condition
Health condition(s) or problem(s) studied:
Raised risk of cardiovascular disease 1594 0
Condition category
Condition code
Cardiovascular 1697 1697 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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 [1] 1128 0
Prevention
Comparator / control treatment
Placebo - one tablet once a day, for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2351 0
Change in systolic blood pressure.
Timepoint [1] 2351 0
Measured at baseline and then at the end of the study (12 weeks).
Primary outcome [2] 2352 0
Change in Low-Density Lipoprotein (LDL)-cholesterol.
Timepoint [2] 2352 0
Measured at baseline and then at the end of the study (12 weeks).
Primary outcome [3] 2353 0
Tolerability (the proportion who withdraw from study treatment).
Timepoint [3] 2353 0
During the study.
Secondary outcome [1] 4097 0
1. Adherence to study medication
Timepoint [1] 4097 0
At study end (12 weeks)
Secondary outcome [2] 4098 0
2. Change in diastolic blood pressure
Timepoint [2] 4098 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [3] 4099 0
3. Change in total cholesterol
Timepoint [3] 4099 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [4] 4100 0
4. Change in High-Density Lipoprotein (HDL)-cholesterol
Timepoint [4] 4100 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [5] 4101 0
5. Change in non-HDL cholesterol
Timepoint [5] 4101 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [6] 4102 0
6. Change in triglycerides
Timepoint [6] 4102 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [7] 4103 0
7. Frequency of switching to open-label treatment
Timepoint [7] 4103 0
During the study
Secondary outcome [8] 4104 0
8. Change in cardiovascular disease (CVD) risk (Framingham)
Timepoint [8] 4104 0
Measured at baseline and then at the end of the study (12 weeks)
Secondary outcome [9] 4105 0
9. Frequency of serious adverse events
Timepoint [9] 4105 0
During the study
Secondary outcome [10] 4106 0
10. Frequency of adverse events
Timepoint [10] 4106 0
During the study

Eligibility
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
Can healthy volunteers participate?
No
Key exclusion criteria
exclusion criteria:1. Life-limiting disease or events

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be randomised by a central computerized randomization program.
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?



Intervention assignment
Parallel
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.
Phase
Phase 3
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
17/10/2008
Actual date of first participant enrolment
2/10/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
18/12/2009
Anticipated date of last data collection
Actual date of last data collection
Target sample size
400
Actual sample size
365
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 232 0
2050
Recruitment outside Australia
Country [1] 331 0
New Zealand
State/province [1] 331 0
Country [2] 332 0
India
State/province [2] 332 0
Country [3] 333 0
Brazil
State/province [3] 333 0
Country [4] 334 0
United Kingdom
State/province [4] 334 0
Country [5] 335 0
United States of America
State/province [5] 335 0
Country [6] 336 0
Netherlands
State/province [6] 336 0

Funding & Sponsors
Funding source category [1] 1838 0
Government body
Name [1] 1838 0
Health Research Council of New Zealand (International Investment Opportunities Fund)
Address [1] 1838 0
PO Box 5541, Wellesley Street, Auckland
Country [1] 1838 0
New Zealand
Funding source category [2] 1839 0
Charities/Societies/Foundations
Name [2] 1839 0
National Heart Foundation of New Zealand (Research Fellowship)
Address [2] 1839 0
P O Box 17-160, Greenlane , Auckland
Country [2] 1839 0
New Zealand
Funding source category [3] 1840 0
Commercial sector/Industry
Name [3] 1840 0
Dr Reddy's Laboratories Limited
Address [3] 1840 0
7-1-27 Ameerpet, Hyderabad 500 016, Andra Pradesh
Country [3] 1840 0
India
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland
Country
New Zealand
Secondary sponsor category [1] 1658 0
None
Name [1] 1658 0
NA
Address [1] 1658 0
NA
Country [1] 1658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3437 0
Northern Y Regional Ethics committee
Ethics committee address [1] 3437 0
Ministry of Health, PO Box 1031, Hamilton
Ethics committee country [1] 3437 0
New Zealand
Date submitted for ethics approval [1] 3437 0
Approval date [1] 3437 0
23/05/2007
Ethics approval number [1] 3437 0
NTY/06/11/111

Summary
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
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
Public notes

Contacts
Principal investigator
Name 36385 0
Prof Anthony Rodgers
Address 36385 0
The George Institute for Global Health, Head Office Level 13, 321 Kent St, Sydney NSW 2000 Australia. Postal Address PO Box M201, Missenden Rd, NSW 2050 Australia
Country 36385 0
Australia
Phone 36385 0
+61 2 9657 0375
Fax 36385 0
Email 36385 0
arodgers@georgeinstitute.org
Contact person for public queries
Name 10317 0
Ms Angela Wadham
Address 10317 0
Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 10317 0
New Zealand
Phone 10317 0
+64 9 3737999
Fax 10317 0
+64 9 3731710
Email 10317 0
a.wadham@auckland.ac.nz
Contact person for scientific queries
Name 1245 0
Prof Anthony Rodgers
Address 1245 0
The George Institute for Global Health, Head Office, Level 13, 321 Kent St, Sydney NSW 2000 Australia, Postal Address PO Box M201, Missenden Rd, NSW 2050 Australia
Country 1245 0
Australia
Phone 1245 0
+61 2 9657 0375
Fax 1245 0
+64 9 3731710
Email 1245 0
arodgers@georgeinstitute.org