Data

Second Australian National Blood Pressure Study

Curtin University

Dataset description

Data description: Data collected from the conduct of the ANBP2 randomised controlled trial conducted from 1994-2001. Data dictionary available from WAHTN Hesanda website Data collection time details: 1994 - 2001 Geographic information (if relevant): Australian participants only Keywords: elderly (65-84 years at study entry), study entry demographics, treatment allocation, annual clinical outcomes
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Source Study

Funding

Commercial sector/Industry,Merck Sharp Dohme

Scientific enquiries

Prof Christopher Reid

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.

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 - Ar ....
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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 consider ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    6083

Min. age    65 Years

Max. age    84 Years

Sex    Both males and females

Condition category    Hypertension

Condition code    Cardiovascular

Intervention

Intervention code Treatment: Drugs

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)

Comparison

Control group Active

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

Outcomes

Outcome: 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: Annually for 5 years post-enrolment

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

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: 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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au