Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT03682692
Eligibility Criteria:
1. the age over 18 years,
2. newly diagnosed grade 1-2 hypertensive patients or grade 1-2 hypertensive patients with monotherapy whose blood pressure not controlled, having systolic blood pressure ranged from 140 to 179 mmHg or (and) diastolic blood pressure ranged from 90 to 109 mmHg,
3. can enter a 4-week run-in period before randomization. During the run-in period, all patients take benazepril 10 mg daily, and have an office visit every two weeks. After taking benazepril for 4 weeks continually with no adverse effect, patients with the mean office blood pressure of the last two visits between 140 and 179 mmHg in systolic or (and) between 90 and 109 mmHg in diastolic are eligible for randomization. Eligible patients will switch to take study medication after randomization. A one-week home blood pressure measurement should be performed before randomization by using an automatic device. Patient should agree to participate in the trial, and can pay follow-up visits.
Exclusion Criteria:
1. suspected or confirmed secondary hypertension
2. history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia
3. other drugs that might affect blood pressure
4. serum levels of ALT, AST, TBL equal or higher than twice of the upper limit
5. serum creatinine ≥1.5 mg/dL (133 μmol/L)
6. urine protein positive
7. serum potassium \>5.5 mmol/L or \<3.5 mmol/L
8. history of gout or serum uric acid ≥420 μmol/L for male or ≥360 μmol/L for female
9. elderly patients need caring
10. patients who are participating other clinical trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03682692
Study Brief:
Protocol Section:
NCT03682692