Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000371392
Ethics application status
Approved
Date submitted
4/06/2008
Date registered
31/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Medical Prophylaxis for the Prevention of Hypertension, Renal Disease and Diabetes in Australian Aborigines
Scientific title
A Randomised Controlled Trial of Medical Prophylaxis for the Prevention of Hypertension, Renal Disease and Diabetes in Australian Aborigines
Universal Trial Number (UTN)
Trial acronym
Tiwi-PPPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 3229 0
Hypertension 3377 0
Renal Disease 3378 0
Condition category
Condition code
Renal and Urogenital 3394 3394 0 0
Kidney disease
Metabolic and Endocrine 3395 3395 0 0
Diabetes
Cardiovascular 3396 3396 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral once daily dosage of Coversyl (Perindopril), a long acting angiotensin converting enzyme inhibitor(ACEi)

Masked participants will be commenced on 5mg of Coversyl (Perindopril) oral daliy for four weeks, then titrated to the full oral daily dose of 10mg Coversyl (Perindopril) where tolerated. Participants are requested to participate in the study for up to 5 years from there date of enrollment.
Intervention code [1] 2972 0
Prevention
Comparator / control treatment
Oral once daily dosage of a Placebo tablet, which is identical, visually, in taste, in smell, in feel and in touch to Coversyl (Perindopril), but inactive in affect.

Masked participants will be commenced on a placebo tablet identical to 5mg Coversyl (Perindopril) oral which will be taken daliy for four weeks, then titrated to a placebo tablet identical to 10mg of Coversyl (Perindopril) which will shall be taken orally daily dose where tolerated.

Participants are requested to participate in the study for up to 5 years from there date of enrollment.
Control group
Placebo

Outcomes
Primary outcome [1] 4290 0
Urine- Albumin Creatinine Ratio (ACR) greater than 3.4 gm/mol
Timepoint [1] 4290 0
Six monthly assessment for five years
Primary outcome [2] 4291 0
Diagnosis of Diabetes as per World Health Organizations guidelines- Two Hour Oral Glucose Tolerance
Timepoint [2] 4291 0
Six monthly assessment for five years
Primary outcome [3] 4292 0
Blood Pressure (BP) greater than 140/90
Timepoint [3] 4292 0
Six monthly assessment for five years
Secondary outcome [1] 7229 0
Body composition changes-Measured by changes in:
Weight in kilograms
Waist in centimeters (measured to the nearest 0.2 cm)
Timepoint [1] 7229 0
Six monthly for five years
Secondary outcome [2] 7230 0
Cardiovascular events- measured by attendance at remote area health services or hospitalization data
Timepoint [2] 7230 0
Monthly data collection on events for Five Years
Secondary outcome [3] 7296 0
Natural deaths- data collected from, remote area health services and office of births, deaths and marriages
Timepoint [3] 7296 0
Monthly data collection on events for five years

Eligibility
Key inclusion criteria
Consenting Tiwi Aboriginal adults age 18+ years
BP less then or equal to 140/90
Urine albumin creatinine ratio less then 3.4 gm/mol
Without diabetes
Who are without contraindications to ACEi.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications to or history of intolerance to ACEi.
Other diseases which might interfere with, or contraindicate treatment.
Emotional or intellectual issues that might invalidate participants consent and/or limit the ability of the participant to comply with protocol requirements.
Women of childbearing potential who are not on long-term contraception.

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)
Allocation concealment by central randomisation service (off site) using a fax and computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization allocation using a computerized software (i.e., sequence generation)
Stratified by gender and location
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3452 0
Charities/Societies/Foundations
Name [1] 3452 0
Colonial Foundation Limited
Country [1] 3452 0
Australia
Funding source category [2] 3453 0
Government body
Name [2] 3453 0
NHMRC- National Health and Medical Research Council
Country [2] 3453 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Chronic Disease
The University of Queensland
Discipline of Medicine
Edith Cavell Building
Royal Brisbane & Women's Hospital
Herston
Queensland
4029
Country
Australia
Secondary sponsor category [1] 3095 0
Other
Name [1] 3095 0
Menzies School of Health Research
Address [1] 3095 0
Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811

Building 58
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Country [1] 3095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5480 0
The University of Queensland-Medical Research Ethics Committee
Ethics committee address [1] 5480 0
The University of Queensland
Brisbane QLD 4072 Australia
Ethics committee country [1] 5480 0
Australia
Date submitted for ethics approval [1] 5480 0
Approval date [1] 5480 0
25/07/2007
Ethics approval number [1] 5480 0
20060000671
Ethics committee name [2] 5481 0
The Human Research Ethics Committee of NT Department of Health and Community Services and Menzies School of Health Research
Ethics committee address [2] 5481 0
Menzies School of Health Research

PO Box 41096
CASUARINA NT 0811

Building 58
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Ethics committee country [2] 5481 0
Australia
Date submitted for ethics approval [2] 5481 0
Approval date [2] 5481 0
10/04/2007
Ethics approval number [2] 5481 0
06/34

Summary
Brief summary
Objective: To evaluate whether the development of albuminuria, hypertension or diabetes can be delayed or postponed in high risk Aboriginal people.
Design. Double blind, placebo controlled, randomized trial of a long acting angiotensin converting enzyme inhibitor(ACEi), titrated to full dose where tolerated (active arm) vs placebo.
Oversight: A steering committee, an independent audit process and a data analysis group.
Eligibility criteria: Consenting Aboriginal adults age 18+ years, with BP = 140/90, urine albumin creatinine ratio < 2.2 gm/mol and without diabetes, who are without contraindications to ACEi.
Outcomes: The primary outcome is a composite endpoint for BP>140/90 and/or urine ACR>2.2 gm/mol and or diabetes. Weight, waist, lipids and HbA1c levels will also be followed. Cardiovascular events and natural deaths will be documented.
Sample size: A total of 150 candidates is proposed: the Tiwi community. These will represent at least 75 in the active arm and 75 in the placebo arm. The sample size is based on factual incidence data in Tiwi.
Duration: Five years of active treatment, with an option to discontinue earlier pending significant results
Significance: Delay of onset of features of the vascular/metabolic/renal syndrome in populations where annual incidence rates are as high as 15% per year, and prevalence rates by age 50 years are = 80% could save or prevent much morbidity and mortality from definitive disease. Findings will probably be relevant to other high risk population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28646 0
Address 28646 0
Country 28646 0
Phone 28646 0
Fax 28646 0
Email 28646 0
Contact person for public queries
Name 11803 0
Mr Suresh Sharma
Address 11803 0
Menzies School of Health Research

PO Box 41096
CASUARINA NT 0811

Building 58
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Country 11803 0
Australia
Phone 11803 0
1800 993 589
Fax 11803 0
08 8927 5197
Email 11803 0
[email protected]
Contact person for scientific queries
Name 2731 0
Dr Wendy Hoy
Address 2731 0
Australia Fellow
Professor of Medicine
Director, Centre for Chronic Disease
The University of Queensland
Discipline of Medicine
Edith Cavell Building
Royal Brisbane & Women's Hospital
Herston Qld 4029
Country 2731 0
Australia
Phone 2731 0
61 7 3346 4809
Fax 2731 0
61 7 3346 4812
Email 2731 0
[email protected]

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

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