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Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

Study acronym: IPAD
StatusRecruiting
PhasePhase 4
SponsorXueQing Yu
Started2018-02-01
View on ClinicalTrials.gov ↗
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular 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 and to be followed up for a median of four years. 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 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.

Amendment history 2 changes detected by DataLookout

2026-09-15
critical
Primary completion pushed: 2025-09 → 2028-09-01
2026-09-15
minor
Completion pushed: 2025-09 → 2029-09-01
Trial Details
NCT Number NCT03264352
Lead Sponsor XueQing Yu
Conditions Diabetes Mellitus, Type 2, Adverse Event, Blood Pressure, Prehypertension, Cardiovascular Risk Factor
Enrollment 11,414 participants
Start Date 2018-02-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-14