Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

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.

Study Overview

• Status: Completed
• Conditions: High-normal Blood Pressure
• Intervention / Treatment: Other: Placebo; Drug: Telmisartan; Drug: Indapamide

• Study Type: Interventional
• Enrollment (Actual): 690
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients will receive a placebo, administered as half a tablet once daily.	Other: Placebo; Patients will receive a placebo, administered as half a tablet once daily.
Experimental: Telmisartan; Patients will receive Telmisartan 40 mg, administered as one tablet once daily.	Drug: Telmisartan; Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
Experimental: Indapamide; Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.	Drug: Indapamide; Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).	New-onset hypertension Incidence of new-onset hypertension during follow-up. Unit of Measure: Number and percentage of participants.; New-onset diabetes Incidence of new-onset diabetes during follow-up. Unit of Measure: Number and percentage of participants.; 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Indoles; Benzene Derivatives; Sulfonamides; Sulfones; Biphenyl Compounds; Telmisartan; Indapamide
• Other Study ID Numbers: 2006BAI01A03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No