ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD)

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD)

2. Rationale:Most current hypertension guidelines recommend the combination therapy of an angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) with a calcium antagonists (CCB) or thiazide diuretics (DIU). However, whether the two combination treatments have similar antihypertensive effects in Chinese hypertensive patients is still lack of clinical evidence, especially randomized controlled trials using ambulatory or home blood pressure measurement as the main evaluation method.

3. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: ACEI/CCB group and ACEI/DIU group.

4. Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria.

5. Randomization and treatment: Potentially eligible patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers and whether receive antihypertensive treatment, eligible patients will be randomly divided into two groups, taking benazepril 10 mg/amlodipine besylate 5mg fixed-dose combination (1 tablet once a day) or benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination (1 tablet once a day).

6. Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months.

7. Sample size estimation: a total of 580 patients should be enrolled in this study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents

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.