Trial Review

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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
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
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
Secondary ID [1] 306246 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ANBP2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 325194 0
Condition category
Condition code
Cardiovascular 322595 322595 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 322806 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 330385 0
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
Timepoint [1] 330385 0
Annually for 5 years post-enrolment
Secondary outcome [1] 406061 0
Nonfatal cardiovascular events - Source data obtained through GP records, hospital records and death records.
Timepoint [1] 406061 0
Annually for 5 years post-enrolment

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
Minimum age
65 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified greater than or equal to 75 years
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/1996
Date of last participant enrolment
Anticipated
Actual
31/12/2001
Date of last data collection
Anticipated
Actual
31/12/2006
Sample size
Target
6000
Accrual to date
Final
6083
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 310594 0
Commercial sector/Industry
Name [1] 310594 0
Merck Sharp Dohme
Country [1] 310594 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
High Blood Pressure Research Council of Australia
Address
PO Box 5436 Chittaway Bay, NSW 2261
Country
Australia
Secondary sponsor category [1] 312150 0
Other
Name [1] 312150 0
Baker Medical Research Institute
Address [1] 312150 0
75 Commercial Road, Melbourne, Victoria 3004, Australia
Country [1] 312150 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310197 0
Royal Australian College of General Practitioners Ethics Committee (RACGP)
Ethics committee address [1] 310197 0
100 Wellington Parade, EAST MELBOURNE VIC 3002
Ethics committee country [1] 310197 0
Australia
Date submitted for ethics approval [1] 310197 0
Approval date [1] 310197 0
31/07/1996
Ethics approval number [1] 310197 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116838 0
Prof Christopher Reid
Address 116838 0
Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
Country 116838 0
Australia
Phone 116838 0
+61 08 9266 7123
Fax 116838 0
Email 116838 0
christopher.reid@curtin.edu.au
Contact person for public queries
Name 116839 0
Prof Christopher Reid
Address 116839 0
Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
Country 116839 0
Australia
Phone 116839 0
+61 08 9266 7123
Fax 116839 0
Email 116839 0
christopher.reid@curtin.edu.au
Contact person for scientific queries
Name 116840 0
Prof Christopher Reid
Address 116840 0
Curtin University
Building 400, Room 213,
Kent Street, Bentley
Western Australia
Australia 6102
Country 116840 0
Australia
Phone 116840 0
+61 08 9266 7123
Fax 116840 0
Email 116840 0
christopher.reid@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data collected at baseline and follow up visits and clinical events
When will data be available (start and end dates)?
Start: January 2023
End: Ongoing
Available to whom?
On request through the WA HeSANDA and ANBP2 Committee
Available for what types of analyses?
Secondary use of clinical trial data meta-analysis, cost effectiveness and other trials
How or where can data be obtained?
WA HeSANDA node (WA-HeSANDA@curtin.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14989Study protocol  WA-HeSANDA@curtin.edu.au
14990Statistical analysis plan  WA-HeSANDA@curtin.edu.au
14991Informed consent form  WA-HeSANDA@curtin.edu.au
14992Ethical approval  WA-HeSANDA@curtin.edu.au



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes February 13, 2003 N Engl J Med 2003; 348:583-592 ... [More Details]

Documents added automatically
No additional documents have been identified.