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

• Status: Active, not recruiting
• Trial end date: 2022-12-01

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

Details

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