Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse
cardiovascular (CV) events. Diabetic patients with hypertension benefit from BP lowering
treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed,
multicenter study involving nearly 12,000 patients to be recruited over three years and to be
followed up for a median of four years and a half. IPAD tests the hypothesis that
antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg
systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major
adverse cardiovascular and cerebrovascular events. During follow-up for participants in the
intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by
titration and combination of the double-blind study medications of an angiotensin type-1
receptor blocker Allisartan (240 mg/day), a dihydropyridine calcium-channel blocker
(amlodipine 5-10 mg/day), and/or other medications if necessary. For those in the standard
group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.