High-normal Blood PressureNCT07652567
Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population
A study testing Telmisartan and Indapamide in people with High-normal Blood Pressure, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- High-normal Blood Pressure
- What is being tested?
- Telmisartan and Indapamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 690 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2007to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subjects deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
- Research Objectives
Primary Objectives:
Read more
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
- Being tested
- Telmisartan, Indapamide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
IndapamideDrug
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
PlaceboOther
Patients will receive a placebo, administered as half a tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive a placebo, administered as half a tablet once daily. Receives: Other: Placebo |
| Telmisartan | Experimental | Patients will receive Telmisartan 40 mg, administered as one tablet once daily. Receives: Drug: Telmisartan |
| Indapamide | Experimental | Patients will receive Indapamide 1.5 mg, administered as one capsule every other day. Receives: Drug: Indapamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jan 2007
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-normal Blood PressureStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652567
- Sponsor's protocol ID
- 2006BAI01A03
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population
- ClinicalTrials.gov ID
- NCT07652567
- Acronym / sponsor ID
- 2006BAI01A03
- Conditions
- High-normal Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPatients will receive a placebo, administered as half a tablet once daily. |
| Telmisartan | Experimental | Drug: TelmisartanPatients will receive Telmisartan 40 mg, administered as one tablet once daily. |
| Indapamide | Experimental | Drug: IndapamidePatients will receive Indapamide 1.5 mg, administered as one capsule every other day. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelmisartanPatients will receive Telmisartan 40 mg, administered as one tablet once daily. | Drug | Telmisartan |
| IndapamidePatients will receive Indapamide 1.5 mg, administered as one capsule every other day. | Drug | Indapamide |
| PlaceboPatients will receive a placebo, administered as half a tablet once daily. | Other | Placebo |
Primary outcome
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Time frame: through study completion, an average of 4 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telmisartan and Indapamide in people with High-normal Blood Pressure, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization). (time frame: through study completion, an average of 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.