HypertensionPhase 4NCT03682692

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

A Phase 4 study testing ACEI/CCB and ACEI/DIU in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: ACEI/CCB and ACEI/DIU
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 560 participants
Where: 1 siteChina
Study dates: 1 Jun 2018to 31 Mar 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025

Other trials in China

About this study

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

Read the detailed description

Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD)
Medicine: Benazepril 10 mg/amlodipine besylate 5 mg fixed-dose combination, benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination.
Rationale: A meta-analysis of 42 studies showed that the combination of two antihypertensive drugs is better than monotherapy to control blood pressure. Most patients with grade 2 or higher hypertension need two or more antihypertensive drugs to control blood pressure. Antihypertensive therapy with fixed-dose combination can better control blood pressure and improve patient compliance, as well as reduce adverse effect. For untreated patients with high blood pressure level, the guidelines recommend that combination therapy can be used initially. The fixed-dose combination can control blood pressure to target, as well as improve patient compliance by reducing the number of tablets. Most current hypertension guidelines, including the Chinese guidelines for the management of hypertension, 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. This randomized controlled clinical trial will be carried out in 580 Chinese hypertensive patients. By measuring office blood pressure, 24-hour ambulatory blood pressure and home blood pressure, the blood pressure lowering effect of benazepril 10 mg/amlodipine besylate 5 mg fixed-dose combination and benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination will be compared.
Objective: The primary objective is to evaluate the reduction of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment. The secondary objectives are to compare the reduction of 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure after 6 months of study medication treatment.
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.
Study population: With the age over 18 years, 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, 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. Exclusion criteria include: 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; or patients who are participating other clinical trials.
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 5 mg 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.
Follow up: All patients should sign an informed consent form before entering the study. A validated Omron automatic device should be used to measure the sitting blood pressure in the clinic. Patients will be followed up every month with sitting office blood pressure measured and medical history recorded. Before each follow-up visit, a one-week home blood pressure measurement should be performed using an automatic Omron device; 24-hour ambulatory blood pressure monitoring, electrocardiogram, blood and urine biochemical tests should be repeated at the end of the 6 months of follow-up.
Sample size estimation: The primary outcome is the reduction of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment. Assuming the difference between groups is 2.5 mmHg and the standard deviation is 10 mmHg, α is 0.05, and the power is 80%, the sample size of each group should be 252 patients. Accounting for 15% of add-up, each group needs 290 eligible patients. The total number of patietns is 580. The data will be analyzed by SAS software, and the t-test will be used to compare the continuous variables of two groups.
Timeline: Ethical review: November 2017; Enrollment: January 2018-June 2020; End of follow-up: December 2020. At the same, abstract of the main results will be submitted to domestic or international scientific conferences. The main results will be published in an international medical journal.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions: Hypertension
Being tested: ACEI/CCB, ACEI/DIU
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACEI/CCBDrug
benazepril 10 mg / amlodipine besylate 5 mg fixed-dose combination
ACEI/DIUDrug
benazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination

Study groups in NCT03682692
Study group	Role	What they receive
ACEI/CCB	Experimental	Not described Receives: Drug: ACEI/CCB
ACEI/DIU	Experimental	Not described Receives: Drug: ACEI/DIU

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months

Secondary outcomes (1)

reduction of other blood pressure measurements
the change of 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure after 6 months of study medication treatment
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201831 Mar 2022

First posted25 Sep 2018
Study start1 Jun 2018
Primary completion30 Jun 2021
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03682692
Sponsor's protocol ID: ACvAD
Status last verified: Feb 2023
First submitted: 18 Sep 2018
Last updated: 14 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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. Antihypertensive treatment effect of two dual therapies according to sodium sensitivity. Hypertens Res. 2026 Feb;49(2):340-349. doi: 10.1038/s41440-025-02382-x. Epub 2025 Oct 6.
PubMed 41053442
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.
PubMed 38263021

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD)
ClinicalTrials.gov ID: NCT03682692
Acronym / sponsor ID: ACvAD
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 560 participants (actual)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 1 Jun 2018 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 25 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD)
Medicine: Benazepril 10 mg/amlodipine besylate 5 mg fixed-dose combination, benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination.
Rationale: A meta-analysis of 42 studies showed that the combination of two antihypertensive drugs is better than monotherapy to control blood pressure. Most patients with grade 2 or higher hypertension need two or more antihypertensive drugs to control blood pressure. Antihypertensive therapy with fixed-dose combination can better control blood pressure and improve patient compliance, as well as reduce adverse effect. For untreated patients with high blood pressure level, the guidelines recommend that combination therapy can be used initially. The fixed-dose combination can control blood pressure to target, as well as improve patient compliance by reducing the number of tablets. Most current hypertension guidelines, including the Chinese guidelines for the management of hypertension, 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. This randomized controlled clinical trial will be carried out in 580 Chinese hypertensive patients. By measuring office blood pressure, 24-hour ambulatory blood pressure and home blood pressure, the blood pressure lowering effect of benazepril 10 mg/amlodipine besylate 5 mg fixed-dose combination and benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination will be compared.
Objective: The primary objective is to evaluate the reduction of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment. The secondary objectives are to compare the reduction of 24-hour, daytime, night-time, home and office systolic and diastolic blood pressure after 6 months of study medication treatment.
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.
Study population: With the age over 18 years, 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, 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. Exclusion criteria include: 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; or patients who are participating other clinical trials.
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 5 mg 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.
Follow up: All patients should sign an informed consent form before entering the study. A validated Omron automatic device should be used to measure the sitting blood pressure in the clinic. Patients will be followed up every month with sitting office blood pressure measured and medical history recorded. Before each follow-up visit, a one-week home blood pressure measurement should be performed using an automatic Omron device; 24-hour ambulatory blood pressure monitoring, electrocardiogram, blood and urine biochemical tests should be repeated at the end of the 6 months of follow-up.
Sample size estimation: The primary outcome is the reduction of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment. Assuming the difference between groups is 2.5 mmHg and the standard deviation is 10 mmHg, α is 0.05, and the power is 80%, the sample size of each group should be 252 patients. Accounting for 15% of add-up, each group needs 290 eligible patients. The total number of patietns is 580. The data will be analyzed by SAS software, and the t-test will be used to compare the continuous variables of two groups.
Timeline: Ethical review: November 2017; Enrollment: January 2018-June 2020; End of follow-up: December 2020. At the same, abstract of the main results will be submitted to domestic or international scientific conferences. The main results will be published in an international medical journal.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
ACEI/CCB	Experimental	Drug: ACEI/CCB
ACEI/DIU	Experimental	Drug: ACEI/DIU

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACEI/CCBbenazepril 10 mg / amlodipine besylate 5 mg fixed-dose combination	Drug	ACEI/CCB
ACEI/DIUbenazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination	Drug	ACEI/DIU

Primary outcome

24-hour ambulatory systolic blood pressure reduction
Time frame: 6 months
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

1 secondary outcome

reduction of other blood pressure measurements
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Derived from this study: PubMed 41053442Huang 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. Antihypertensive treatment effect of two dual therapies according to sodium sensitivity. Hypertens Res. 2026 Feb;49(2):340-349. doi: 10.1038/s41440-025-02382-x. Epub 2025 Oct 6.
Derived from this study: PubMed 38263021Huang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ACEI/CCB and ACEI/DIU in people with Hypertension, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour ambulatory systolic blood pressure reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03682692, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.