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Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes (IPAD)
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.
Details
| Lead sponsor | XueQing Yu |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 11414 |
| Start date | 2018-02-01 |
| Completion | 2025-09 |
Conditions
- Diabetes Mellitus, Type 2
- Adverse Event
- Blood Pressure
- Prehypertension
- Cardiovascular Risk Factor
Interventions
- Allisartan Isoproxil
- Amlodipine 5mg
- Standard treatment by current guideline
Primary outcomes
- Composite of Major Adverse Cardiovascular and Cerebrovascular Events — From date of randomization until the date of first documented incidence of the major adverse cardiovascular events prespecified, whichever comes first, assessed up to 60 months
The major adverse cardiovascular and cerebrovascular events defined in the study include cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, hospitalization for congestive heart failure and hospitalization for unstable angina.
Countries
China