Actively Recruiting

Phase 4
Age: 45Years - 79Years
All Genders
NCT03264352

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

Age: 45Years - 79Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Guangdong General Hospital

Guangzhou, Guangdong, China, 501080

Actively Recruiting

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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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