Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

NCT07652567 | Completed

• 1 other identifier: 2006BAI01A03
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).

  1. New-onset hypertension Incidence of new-onset hypertension during follow-up. Unit of Measure: Number and percentage of participants. 2. New-onset diabetes Incidence of new-onset diabetes during follow-up. Unit of Measure: Number and percentage of participants. 3. Composite cardiovascular events Incidence of composite cardiovascular events during follow-up, defined as the occurrence of at least one of the following: fatal or non-fatal stroke, myocardial infarction, cardiovascular death, or coronary revascularization. Participants with multiple events will be counted once for the composite endpoint. Unit of Measure: Number and percentage of participants.

  through study completion, an average of 4 year

Other Outcomes (1)

• Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.

  through study completion, an average of 4 year

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo, administered as half a tablet once daily.

Other: Placebo

Telmisartan

EXPERIMENTAL

Patients will receive Telmisartan 40 mg, administered as one tablet once daily.

Drug: Telmisartan

Indapamide

EXPERIMENTAL

Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.

Drug: Indapamide

Interventions

Telmisartan DRUG

Patients will receive Telmisartan 40 mg, administered as one tablet once daily.

Telmisartan

Indapamide DRUG

Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.

Indapamide

Placebo OTHER

Patients will receive a placebo, administered as half a tablet once daily.

Placebo

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 50-79 years, regardless of sex.
• Blood Pressure: Systolic blood pressure (SBP) 130 ≤ SBP \< 140 mmHg and/or diastolic blood pressure (DBP) 85 ≤ DBP \< 90 mmHg.
• Presence of at least one cardiovascular risk factor.
• Capacity to provide informed consent.

You may not qualify if:

• Diabetes mellitus (FPG ≥ 7.0 mmol/L and/or OGTT 2h PG ≥ 11.1 mmol/L).
• Hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg) or current use of antihypertensive medication.
• Participation in another clinical trial within 3 months prior to enrollment or concurrently with this study.
• Significant renal impairment (serum creatinine ≥ 2.5 mg/dL).
• Significant hepatic dysfunction (ALT \> 2 × upper limit of normal \[ULN\]).
• Serum potassium \< 3.5 mmol/L or \> 5.6 mmol/L.
• Known hypersensitivity to the investigational drugs used in this study.
• History of stroke or myocardial infarction within 3 months prior to study entry.
• Undergoing or scheduled for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to study start.
• Other serious medical conditions (e.g., malignant tumors).
• Pregnant women or women of childbearing potential who are not using effective contraception or likely to become pregnant.
• Patients who are bedridden or unable to attend clinic visits.
• Any other condition requiring antihypertensive medication.
• Any indication or contraindication for the investigational drug or other antihypertensive agents.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

Telmisartan; Indapamide

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Indoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 17, 2026
• Study Start: January 1, 2007
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-05

Locations

CN (1)