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

NCT03682692 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2023-02-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ACEI/CCB

benazepril 10 mg / amlodipine besylate 5 mg fixed-dose combination

DRUG

ACEI/DIU

benazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-06-30
Completion
2022-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682692 on ClinicalTrials.gov