RecruitingPhase 4NCT03264352

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


Sponsor

XueQing Yu

Enrollment

11,414 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 45 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether treating adults with type 2 diabetes who have mildly elevated blood pressure (what used to be called "prehypertension") with blood pressure medication can reduce the risk of serious complications. You may be eligible if: you are between 45 and 79 years old (any sex); your sitting blood pressure is between 120–139 mmHg systolic and below 90 mmHg diastolic; you have type 2 diabetes and are currently receiving diabetes treatment; and you are able to be followed up long-term. You may NOT be eligible if: your blood sugar is very poorly controlled (HbA1c above 10%); you have taken blood pressure medication in the past month; you have a history of severe low blood sugar events; you have serious liver, kidney, or heart problems; or you are pregnant or breastfeeding. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAllisartan Isoproxil

Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.

DRUGAmlodipine 5mg

Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).

OTHERStandard treatment by current guideline

No BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.


Locations(1)

Guangdong General Hospital

Guangzhou, Guangdong, China

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NCT03264352


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