Status:
RECRUITING
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Lead Sponsor:
XueQing Yu
Conditions:
Diabetes Mellitus, Type 2
Adverse Event
Eligibility:
All Genders
45-79 years
Phase:
PHASE4
Brief 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 trea...
Detailed Description
The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited in three years with a median follow up of four years. IPAD tests the hypothesis that...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
11414 Patients enrolled
Trial Details
Trial ID
NCT03264352
Start Date
February 1 2018
End Date
September 1 2025
Last Update
March 12 2025
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 501080