Actively Recruiting
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Led by XueQing Yu · Updated on 2025-03-12
11414
Participants Needed
1
Research Sites
395 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Irrespective of sex
- Aged between 45 and 79 years
- Office-measured seated blood pressure 120-139 mm Hg systolic and below 90 mm Hg diastolic
- Diagnosed with type 2 diabetes mellitus and currently on diabetic therapy
- Provided informed consent and able to participate in long-term follow-up
You will not qualify if you...
- Poor blood glucose control with HbA1c over 10.0%
- Use of any antihypertensive medications within the past month
- History of hypoglycemic coma or seizure
- Confirmed diagnosis of type 1 diabetes mellitus
- Liver enzymes (ALT or AST) over three times the upper normal limit
- Estimated glomerular filtration rate below 45 ml/min/1.73m2
- History of congestive heart failure with left ventricular ejection fraction below 40%
- Coronary artery disease requiring RAS blockers for secondary prevention
- Acute stroke within 6 months before randomization
- Urinary albumin to creatinine ratio 300 mg/g or higher
- Known contraindications to study medications
- History of psychological or mental disorders
- Pregnancy, planning pregnancy, or breastfeeding
- Severe heart diseases or other severe illnesses
- Expected life span less than 3 years
- Malignancy deemed unsuitable by investigators
- Currently participating in another clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong General Hospital
Guangzhou, Guangdong, China, 501080
Actively Recruiting
Research Team
J
Jiyan Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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