NCT03264352RecruitingPhase 4
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 11414 (estimated)
- First submitted
- 21 Aug 2017
- Start date
- 1 Feb 2018
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- XueQing Yu
- Diseases
- Type 2 diabetes
- NCT number
- NCT03264352
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 11414
- From 1 Feb 2018 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- administration of any antihypertensive medications within 1 month;
- acute on-set of stroke within 6 months prior to randomization;
- known contraindications for the active study medications;
Other illness
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- coronary artery disease requiring RAS blockers for secondary prevention;
- a history of psychological or mental disorder;
- severe diseases such as severe heart diseases;
- a malignancy that clinical investigators consider as unsuitable to participate;
Lab values
- poor control of blood glucose, HbA1c \> 10.0%
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- a history of congestive heart failure with left ventricular ejection fraction \< 40%;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
Other
- estimated glomerular filtration rate \< 45 ml/min/1.73m2;
- pregnancy or currently planning to have babies or lactation;
- an expected residual life span less than 3 years;
- currently participating in another clinical trial.
Who the study is looking for
- 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
Age in the registry: 45 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.