ANBP2
ACTRN12622000398707
Treatment
Phase 4
Commercial sector/Industry,Merck Sharp Dohme
Prof Christopher Reid
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.
- 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 .... Read more
- 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 .... Read more
No
Sample Size 6083
Min. age 65 Years
Max. age 84 Years
Sex Both males and females
Condition category Hypertension
Condition code Cardiovascular
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)
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
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 indexTimepoint: Annually for 5 years post-enrolment
yes
Individual patient data collected at baseline and follow up visits and clinical events
Start: January 2023 End: Ongoing
On request through the WA HeSANDA and ANBP2 Committee
Secondary use of clinical trial data meta-analysis, cost effectiveness and other trials