Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population
NCT07652567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 690
Last updated 2026-06-17
Summary
I. Research Objectives
Primary Objectives:
To evaluate the effect of low-dose antihypertensive therapy on the incidence of new-onset hypertension and new-onset diabetes in individuals with high-normal blood pressure and cardiovascular risk factors.
To assess the impact of low-dose antihypertensive therapy on composite cardiovascular events in individuals with high-normal blood pressure and cardiovascular risk factors.
Secondary Objective:
To evaluate the effects of low-dose antihypertensive therapy and different drug regimens on intermediate markers or subclinical status of cardiovascular disease risk, including lipid profiles, carotid atherosclerosis, and arterial stiffness (pulse wave velocity).
II. Study Population Individuals with high-normal blood pressure and comorbid cardiovascular risk factors who have not been treated with antihypertensive medications.
III. Endpoints
Primary Endpoints:
New-onset hypertension and new-onset diabetes. Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Other Endpoints:
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
Conditions
- High-normal Blood Pressure
Interventions
- DRUG
-
Telmisartan
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
- DRUG
-
Indapamide
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
- OTHER
-
Placebo
Patients will receive a placebo, administered as half a tablet once daily.
Sponsors & Collaborators
-
Qilu Hospital of Shandong University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-01
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- China
Study Locations
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