Clinical trial
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Name
GDREC2017192H
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.
Trial arms
Trial start
2018-02-01
Estimated PCD
2025-09-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Allisartan Isoproxil
Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
Arms:
intensive treatment group
Other names:
Xinlitan
Amlodipine 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).
Arms:
intensive treatment group
Other names:
Qiaohean
Standard 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.
Arms:
standard treatment group
Size
11414
Primary endpoint
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
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* poor control of blood glucose, HbA1c \> 10.0%
* administration of any antihypertensive medications within 1 month;
* a history of hypoglycemic coma / seizure;
* confirmed diagnosis of type 1 diabetes mellitus;
* alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
* estimated glomerular filtration rate \< 45 ml/min/1.73m2;
* a history of congestive heart failure with left ventricular ejection fraction \< 40%;
* coronary artery disease requiring RAS blockers for secondary prevention;
* acute on-set of stroke within 6 months prior to randomization;
* a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
* known contraindications for the active study medications;
* a history of psychological or mental disorder;
* pregnancy or currently planning to have babies or lactation;
* severe diseases such as severe heart diseases;
* an expected residual life span less than 3 years;
* a malignancy that clinical investigators consider as unsuitable to participate;
* currently participating in another clinical trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 11414, 'type': 'ESTIMATED'}}
Updated at
2023-02-23
1 organization
2 products
6 indications
Organization
Xueqing YuProduct
Allisartan IsoproxilIndication
Diabetes MellitusIndication
Type 2Indication
Adverse EventIndication
HypertensionIndication
Stage 1 hypertensionIndication
Cardiovascular Risk FactorProduct
Amlodipine