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

Trial details

Who runs it

XueQing Yu

Trial code

NCT03264352

Record updated

14 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: irrespective of sex; aged between 45 and 79 years; with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic; diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy; informed consent provided and long-term follow-up possible.

Exclusion: administration of any antihypertensive medications within 1 month; acute on-set of stroke within 6 months prior to randomization; known contraindications for the active study medications; a history of hypoglycemic coma / seizure; confirmed diagnosis of type 1 diabetes mellitus; coronary artery disease requiring RAS blockers for secondary prevention; a history of psychological or mental disorder; severe diseases such as severe heart diseases; a malignancy that clinical investigators consider as unsuitable to participate; poor control of blood glucose, HbA1c > 10.0%; alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal; a history of congestive heart failure with left ventricular ejection fraction < 40%; a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g; estimated glomerular filtration rate < 45 ml/min/1.73m2; pregnancy or currently planning to have babies or lactation; an expected residual life span less than 3 years; currently participating in another clinical trial.

ClinicalTrials.gov NCT03264352