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Trial registered on ANZCTR
Registration number
ACTRN12622000398707
Ethics application status
Approved
Date submitted
16/02/2022
Date registered
8/03/2022
Date last updated
8/03/2022
Date data sharing statement initially provided
8/03/2022
Date results information initially provided
8/03/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Second Australian National Blood Pressure Study (ANBP2): Effect of Angiotensin-Converting Enzyme (ACE) Inhibitor and Diuretic-based Treatment on rates of cardiovascular-associated mortality in the Elderly
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Scientific title
Australian Comparative Trial of the effect of Angiotensin-Converting Enzyme (ACE) Inhibitor and Diuretic-based Treatment of Hypertension on rates of cardiovascular-associated mortality in the Elderly
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Secondary ID [1]
306246
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
ANBP2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
325194
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Condition category
Condition code
Cardiovascular
322595
322595
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dose: 5mg of ACE inhibitor enalapril as per GP's directions
Duration: Life-long
Mode: Oral tablet
Once daily dose: Adherence monitored by GP questioning (no tablet returns or laboratory tests)
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Intervention code [1]
322806
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Treatment: Drugs
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Comparator / control treatment
This was an active / comparator group study so the control was active treatment with diuretic
Oral daily therapy however drug, dose, and frequency was as per GP discretion and not protocol driven
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Control group
Active
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Outcomes
Primary outcome [1]
330385
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COMPOSITE PRIMARY OUTCOME : ALL CAUSE mortality and CVD events
Data was collected through death record certificates and medical record reviews and links to the national death index
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Assessment method [1]
330385
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Timepoint [1]
330385
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Annually for 5 years post-enrolment
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Secondary outcome [1]
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Nonfatal cardiovascular events - Source data obtained through GP records, hospital records and death records.
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Assessment method [1]
406061
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Timepoint [1]
406061
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Annually for 5 years post-enrolment
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Eligibility
Key inclusion criteria
- Are 65-84 years of age
- Confirmed hypertension, either untreated or previously treated, with average untreated sitting blood pressure on the 2nd and 3rd screening visits of the study greater than or equal to 160 mmHg or greater than or equal to90 mmHg diastolic (if systolic BP is greater than or equal to 140 mmHg)
- Have no history of recent cardiovascular morbidity (see under exclusion criteria), serious intercurrent illness or a absolute contraindication to an ACE inhibitor or diuretic
- Are capable of and willing to give informed consent
- Are ambulant and able to attend their general practitioner's practise throughout the study
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Minimum age
65
Years
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Maximum age
84
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prescence of any previous nonfatal cardiovascular event which defines an end-point for the study in the past 6 months. Refers to any existing condition (eg cancer) which the GP feels is likely to cause death with 5 years.
- Accelerated or malignant hypertension
- Dementia
- Plasma creatinine concentration > 0.2mmol/l. The measurement should have been within the past 12 months or, if this is not available, will be undertaken at the initial screening visit
- Any life threatening illness considered to be likely to cause death within the study's observation period (5 years)
- Presence of any absolute contraindication to or specific indication for an ACE inhibitor or a diuretic
- Consideration by the subject's general practitioner that the subject is unsuitable for the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified greater than or equal to 75 years
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/07/1996
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Date of last participant enrolment
Anticipated
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Actual
31/12/2001
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Date of last data collection
Anticipated
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Actual
31/12/2006
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Sample size
Target
6000
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Accrual to date
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Final
6083
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
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Funding & Sponsors
Funding source category [1]
310594
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Commercial sector/Industry
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Name [1]
310594
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Merck Sharp Dohme
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Address [1]
310594
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Building A - Level 1/26 Talavera Rd, Macquarie Park NSW 2113
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Country [1]
310594
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
High Blood Pressure Research Council of Australia
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Address
PO Box 5436 Chittaway Bay, NSW 2261
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Country
Australia
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Secondary sponsor category [1]
312150
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Other
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Name [1]
312150
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Baker Medical Research Institute
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Address [1]
312150
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75 Commercial Road, Melbourne, Victoria 3004, Australia
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Country [1]
312150
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Australian College of General Practitioners Ethics Committee (RACGP)
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Ethics committee address [1]
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100 Wellington Parade, EAST MELBOURNE VIC 3002
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
310197
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Approval date [1]
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31/07/1996
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Ethics approval number [1]
310197
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Summary
Brief summary
To determine in hypertensive subjects of 65-84 years of age whether there is any difference in total cardiovascualr events (fatal and non-fatal) over a five year treatment period between antihypertensive treatment with ACE inhibitor-based regimen and treatment with a diuretic-based regimen.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
116838
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Prof Christopher Reid
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Address
116838
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Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
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Country
116838
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Australia
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Phone
116838
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+61 08 9266 7123
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Fax
116838
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Email
116838
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[email protected]
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Contact person for public queries
Name
116839
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Prof Christopher Reid
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Address
116839
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Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
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Country
116839
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Australia
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Phone
116839
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+61 08 9266 7123
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Fax
116839
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Email
116839
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[email protected]
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Contact person for scientific queries
Name
116840
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Prof Christopher Reid
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Address
116840
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Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
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Country
116840
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Australia
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Phone
116840
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+61 08 9266 7123
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Fax
116840
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Email
116840
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual patient data collected at baseline and follow up visits and clinical events
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When will data be available (start and end dates)?
Start: January 2023
End: Ongoing
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Available to whom?
On request through the WA HeSANDA and ANBP2 Committee
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Available for what types of analyses?
Secondary use of clinical trial data meta-analysis, cost effectiveness and other trials
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How or where can data be obtained?
WA HeSANDA node (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14989
Study protocol
[email protected]
14990
Statistical analysis plan
[email protected]
14991
Informed consent form
[email protected]
14992
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
February 13, 2003 N Engl J Med 2003; 348:583-592 ...
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Documents added automatically
No additional documents have been identified.
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