Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12607000099426
Ethics application status
Approved
Date submitted
4/10/2006
Date registered
30/01/2007
Date last updated
3/06/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Programme to Improve Life and Longevity Pilot
Query!
Scientific title
Is a polypill tolerable and effective at improving blood pressure and cholesterol control in people at raised risk of cardiovascular disease
Query!
Secondary ID [1]
273460
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PILL Pilot
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Raised risk of cardiovascular disease
1594
0
Query!
Condition category
Condition code
Cardiovascular
1697
1697
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
1128
0
Prevention
Query!
Comparator / control treatment
Placebo - one tablet once a day, for 12 weeks.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
2351
0
Change in systolic blood pressure.
Query!
Assessment method [1]
2351
0
Query!
Timepoint [1]
2351
0
Measured at baseline and then at the end of the study (12 weeks).
Query!
Primary outcome [2]
2352
0
Change in Low-Density Lipoprotein (LDL)-cholesterol.
Query!
Assessment method [2]
2352
0
Query!
Timepoint [2]
2352
0
Measured at baseline and then at the end of the study (12 weeks).
Query!
Primary outcome [3]
2353
0
Tolerability (the proportion who withdraw from study treatment).
Query!
Assessment method [3]
2353
0
Query!
Timepoint [3]
2353
0
During the study.
Query!
Secondary outcome [1]
4097
0
1. Adherence to study medication
Query!
Assessment method [1]
4097
0
Query!
Timepoint [1]
4097
0
At study end (12 weeks)
Query!
Secondary outcome [2]
4098
0
2. Change in diastolic blood pressure
Query!
Assessment method [2]
4098
0
Query!
Timepoint [2]
4098
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [3]
4099
0
3. Change in total cholesterol
Query!
Assessment method [3]
4099
0
Query!
Timepoint [3]
4099
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [4]
4100
0
4. Change in High-Density Lipoprotein (HDL)-cholesterol
Query!
Assessment method [4]
4100
0
Query!
Timepoint [4]
4100
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [5]
4101
0
5. Change in non-HDL cholesterol
Query!
Assessment method [5]
4101
0
Query!
Timepoint [5]
4101
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [6]
4102
0
6. Change in triglycerides
Query!
Assessment method [6]
4102
0
Query!
Timepoint [6]
4102
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [7]
4103
0
7. Frequency of switching to open-label treatment
Query!
Assessment method [7]
4103
0
Query!
Timepoint [7]
4103
0
During the study
Query!
Secondary outcome [8]
4104
0
8. Change in cardiovascular disease (CVD) risk (Framingham)
Query!
Assessment method [8]
4104
0
Query!
Timepoint [8]
4104
0
Measured at baseline and then at the end of the study (12 weeks)
Query!
Secondary outcome [9]
4105
0
9. Frequency of serious adverse events
Query!
Assessment method [9]
4105
0
Query!
Timepoint [9]
4105
0
During the study
Query!
Secondary outcome [10]
4106
0
10. Frequency of adverse events
Query!
Assessment method [10]
4106
0
Query!
Timepoint [10]
4106
0
During the study
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
exclusion criteria:1. Life-limiting disease or events
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be randomised by a central computerized randomization program.
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
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.
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
17/10/2008
Query!
Actual
2/10/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
18/12/2009
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
400
Query!
Accrual to date
Query!
Final
365
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment postcode(s) [1]
232
0
2050
Query!
Recruitment outside Australia
Country [1]
331
0
New Zealand
Query!
State/province [1]
331
0
Query!
Country [2]
332
0
India
Query!
State/province [2]
332
0
Query!
Country [3]
333
0
Brazil
Query!
State/province [3]
333
0
Query!
Country [4]
334
0
United Kingdom
Query!
State/province [4]
334
0
Query!
Country [5]
335
0
United States of America
Query!
State/province [5]
335
0
Query!
Country [6]
336
0
Netherlands
Query!
State/province [6]
336
0
Query!
Funding & Sponsors
Funding source category [1]
1838
0
Government body
Query!
Name [1]
1838
0
Health Research Council of New Zealand (International Investment Opportunities Fund)
Query!
Address [1]
1838
0
PO Box 5541, Wellesley Street, Auckland
Query!
Country [1]
1838
0
New Zealand
Query!
Funding source category [2]
1839
0
Charities/Societies/Foundations
Query!
Name [2]
1839
0
National Heart Foundation of New Zealand (Research Fellowship)
Query!
Address [2]
1839
0
P O Box 17-160, Greenlane , Auckland
Query!
Country [2]
1839
0
New Zealand
Query!
Funding source category [3]
1840
0
Commercial sector/Industry
Query!
Name [3]
1840
0
Dr Reddy's Laboratories Limited
Query!
Address [3]
1840
0
7-1-27 Ameerpet, Hyderabad 500 016, Andra Pradesh
Query!
Country [3]
1840
0
India
Query!
Primary sponsor type
Government body
Query!
Name
Health Research Council of New Zealand
Query!
Address
PO Box 5541, Wellesley Street, Auckland
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
1658
0
None
Query!
Name [1]
1658
0
NA
Query!
Address [1]
1658
0
NA
Query!
Country [1]
1658
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
3437
0
Northern Y Regional Ethics committee
Query!
Ethics committee address [1]
3437
0
Ministry of Health, PO Box 1031, Hamilton
Query!
Ethics committee country [1]
3437
0
New Zealand
Query!
Date submitted for ethics approval [1]
3437
0
Query!
Approval date [1]
3437
0
23/05/2007
Query!
Ethics approval number [1]
3437
0
NTY/06/11/111
Query!
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.
Query!
Trial website
Query!
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
Query!
Public notes
Query!
Contacts
Principal investigator
Name
36385
0
Prof Anthony Rodgers
Query!
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
Query!
Country
36385
0
Australia
Query!
Phone
36385
0
+61 2 9657 0375
Query!
Fax
36385
0
Query!
Email
36385
0
[email protected]
Query!
Contact person for public queries
Name
10317
0
Ms Angela Wadham
Query!
Address
10317
0
Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Query!
Country
10317
0
New Zealand
Query!
Phone
10317
0
+64 9 3737999
Query!
Fax
10317
0
+64 9 3731710
Query!
Email
10317
0
[email protected]
Query!
Contact person for scientific queries
Name
1245
0
Prof Anthony Rodgers
Query!
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
Query!
Country
1245
0
Australia
Query!
Phone
1245
0
+61 2 9657 0375
Query!
Fax
1245
0
+64 9 3731710
Query!
Email
1245
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF