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

NCT03682692 | Completed Phase 4 DMC

• 1 other identifier: ACvAD
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD)
2. 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. 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. 4.Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria.
5. 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. 6.Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months.
7. 7.Sample size estimation: a total of 580 patients should be enrolled in this study.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 24-hour ambulatory systolic blood pressure reduction

  the change of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment

  6 months

Secondary Outcomes (1)

• reduction of other blood pressure measurements

  6 months

Study Arms (2)

ACEI/CCB

EXPERIMENTAL

Drug: ACEI/CCB

ACEI/DIU

EXPERIMENTAL

Drug: ACEI/DIU

Interventions

ACEI/CCB DRUG

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

ACEI/CCB

ACEI/DIU DRUG

benazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination

ACEI/DIU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• suspected or confirmed secondary hypertension
• history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia
• other drugs that might affect blood pressure
• serum levels of ALT, AST, TBL equal or higher than twice of the upper limit
• serum creatinine ≥1.5 mg/dL (133 μmol/L)
• urine protein positive
• serum potassium \>5.5 mmol/L or \<3.5 mmol/L
• history of gout or serum uric acid ≥420 μmol/L for male or ≥360 μmol/L for female
• elderly patients need caring
• patients who are participating other clinical trials.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Related Publications (1)

• Huang QF, Zhang D, Luo Y, Hu K, Wu Q, Qiu H, Xu F, Wang ML, Chen X, Li Y, Wang JG; ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD) investigators. Comparison of two single-pill dual combination antihypertensive therapies in Chinese patients: a randomized, controlled trial. BMC Med. 2024 Jan 24;22(1):28. doi: 10.1186/s12916-023-03244-4.

  PMID: 38263021 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: 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). If the systolic/diastolic blood pressure higher than 140/90 mmHg during follow-up visits, the dosage can be increased to 2 tablets once a day. If the systolic/diastolic blood pressure still ≥140/90 mmHg, bisoprolol 5 mg (1 tablet once a day) or doxazosin controlled-release tablets 4 mg (1 tablet once a day) or spironolactone 20 mg (1 tablet once a day) can be added during the following follow-up visits.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 25, 2018
• Study Start: June 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: March 31, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)