HypertensionPhase 4NCT04931108

The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

1. Study name: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability. 2. Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol. 3. Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Hypertension
What is being tested?: Nitrendipine/Atenolol, Nitrendipine and Atenolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 27 Sep 2021to Jun 2023
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 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or Women.
Aged 30-65 years.
Ambulatory systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg.
Ambulatory daytime systolic blood pressure standard deviation (SD)≥13mmHg.
Never took antihypertensive drugs.
Signed the written consent.

Who cannot join

Under antihypertensive treatments.
Clinic systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg.
Contraindications to the treatment of drugs, including hypersensitivity reaction, bradycardia, asthma, etc.
Any cardiovascular disease except hypertension.
Suspected or confirmed secondary hypertension.
Poor compliance.

Trial locations and contacts

1 site in 1 country.

Jiguang Wang, MD, PhD contact

+86-21-64370045 ext. 610911

jiguangw@163.com

China1 site, 1 recruiting

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jiguang Wang, MD, PhD, 86-21-64370045 ext. 610911, jiguangw@163.com
Recruiting

Other trials in China

About this study

Official title: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability of Patients With Grade 1 Hypertension Compared With Nitrendipine or Atenolol Monotherapy.

Study name: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol.
Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Nitrendipine/Atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown.
Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Study design: This study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: Nitrendipine/Atenolol (5mg/10mg); Nitrendipine (10mg) or atenolol (25mg).
Study population: Men and Women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria.
Randomization and cross-over design: Eligible patients will be randomly divided into two groups. Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Follow up: 14 weeks.
Sample size: a total of 32 patients should be enrolled.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.

Read the detailed description

Study name: The effect of Nitrendipine/Atenolol combination on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Medicine: Nitrendipine/Atenolol (5/10mg tablet); Nitrendipine (10mg tablet); Atenolol (25mg tablet)
Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Nitrendipine/Atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown.
Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Study design: This study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: Nitrendipine/Atenolol (5mg/10mg); Nitrendipine (10mg) or atenolol (25mg).
Study population: Eligible patients (n=32) should be men or women aged 30-65 years. Untreated patients diagnosed as essential hypertension, whose daytime systolic blood pressure ≥ 135mmHg and/or daytime diastolic blood pressure ≥ 85mmHg, and standard deviation (SD)≥13mmHg will be recruited.
Randomization and cross-over design: Eligible patients will be randomly divided into two groups. Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Follow up: 14 weeks. 1 week for screening period, 6 weeks for the first period of treatment, 1 week for wash-out period, and 6 weeks for the second period of treatment.
Sample size: a total of 32 patients should be enrolled.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions: Hypertension
Being tested: Nitrendipine/Atenolol, Nitrendipine, Atenolol
Keywords: blood pressure variability, nitrendipine, atenolol
Medical subject headings: Hypertension

What participants receive

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

Nitrendipine/AtenololDrug
Also called Nitrendipine and Atenolol Tablets
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
NitrendipineDrug
Also called Nitrendipine Tablets
Nitrendipine 5mg, oral tablet, one pill daily.
AtenololDrug
Also called Atenolol Tablets
Atenolol 25mg, oral tablet, one pill daily.

Study groups in NCT04931108
Study group	Role	What they receive
Sequence 1	Experimental	One pill of nitrendipine/atenolol combination (5/10mg) once daily for 6 weeks first, and followed by monotherapy for another 6 weeks, when patients will evenly assigned to one pill of nitrendipine (10mg) or one pill of atenolol (25mg) once daily. Receives: Drug: Nitrendipine/Atenolol; Drug: Nitrendipine; Drug: Atenolol
Sequence 2	Experimental	Monotherapy for 6 weeks first, when patients will evenly assigned to one pill of nitrendipine (10mg) or one pill of atenolol (25mg) once daily, followed by one pill of nitrendipine/atenolol combination (5/10mg) once daily for another 6 weeks. Receives: Drug: Nitrendipine/Atenolol; Drug: Nitrendipine; Drug: Atenolol

What is being measured

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

Ambulatory systolic blood pressure variability 1
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).
Measured: The first 6 weeks of treatment.
Ambulatory systolic blood pressure variability 2
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).
Measured: The second 6 weeks of cross-over treatment.

Secondary outcomes (4)

Ambulatory diastolic blood pressure variability 1
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).
Measured: The first 6 weeks of treatment.
Ambulatory diastolic blood pressure variability 2
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).
Measured: The second 6 weeks of cross-over treatment.
Ambulatory blood pressure 1
Including ambulatory blood pressure over 24 hours, daytime and nighttime.
Measured: The first 6 weeks of treatment.
Ambulatory blood pressure 2
Including ambulatory blood pressure over 24 hours, daytime and nighttime.
Measured: The second 6 weeks of cross-over treatment.

Timeline

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

27 Sep 2021Jun 2023

First posted18 Jun 2021
Study start27 Sep 2021
Primary completionJun 2023 (estimated)
Study completionJun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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: Crossover
Model description: Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04931108
Sponsor's protocol ID: NAC-BPV
Status last verified: Apr 2023
First submitted: 27 May 2021
Last updated: 14 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xia JH, Cheng YB, Xu TY, Guo QH, Chan CM, Hu LX, Li Y, Wang JG. Effect of a calcium-channel blocker and beta-blocker combination on reading-to-reading blood pressure variability: a randomized crossover trial. Blood Press Monit. 2025 Apr 1;30(2):73-81. doi: 10.1097/MBP.0000000000000736. Epub 2024 Nov 26.
PubMed 39831760

Want to know more?

Jiguang Wang, MD, PhD

+86-21-64370045 ext. 610911

jiguangw@163.com

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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability of Patients With Grade 1 Hypertension Compared With Nitrendipine or Atenolol Monotherapy.
ClinicalTrials.gov ID: NCT04931108
Acronym / sponsor ID: NAC-BPV
Conditions: Hypertension
Keywords: blood pressure variability, nitrendipine, atenolol
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 32 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 27 Sep 2021 (actual)
Primary completion: Jun 2023 (estimated)
Study completion: Jun 2023 (estimated)
First posted: 18 Jun 2021 (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: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol.
Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Nitrendipine/Atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown.
Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Study design: This study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: Nitrendipine/Atenolol (5mg/10mg); Nitrendipine (10mg) or atenolol (25mg).
Study population: Men and Women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria.
Randomization and cross-over design: Eligible patients will be randomly divided into two groups. Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Follow up: 14 weeks.
Sample size: a total of 32 patients should be enrolled.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.

Detailed description

Study name: The effect of Nitrendipine/Atenolol combination on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Medicine: Nitrendipine/Atenolol (5/10mg tablet); Nitrendipine (10mg tablet); Atenolol (25mg tablet)
Rationale: Blood pressure variability correlates with cardiovascular events and target-organ damage in hypertensive patients. Nitrendipine/Atenolol has obvious advantages in reducing blood pressure variability in hypertensive rats, but the effect of this combination on hypertensive patients is still unknown.
Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
Study design: This study is a cross-over, randomized, controlled clinical trial with two equally sized treatment groups: Nitrendipine/Atenolol (5mg/10mg); Nitrendipine (10mg) or atenolol (25mg).
Study population: Eligible patients (n=32) should be men or women aged 30-65 years. Untreated patients diagnosed as essential hypertension, whose daytime systolic blood pressure ≥ 135mmHg and/or daytime diastolic blood pressure ≥ 85mmHg, and standard deviation (SD)≥13mmHg will be recruited.
Randomization and cross-over design: Eligible patients will be randomly divided into two groups. Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.
Follow up: 14 weeks. 1 week for screening period, 6 weeks for the first period of treatment, 1 week for wash-out period, and 6 weeks for the second period of treatment.
Sample size: a total of 32 patients should be enrolled.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Half of patients will take nitrendipine/atenolol (5/10mg) once daily for 6 weeks first, and then evenly turn into nitrendipine (10mg) or atenolol (25mg) once daily for 6 weeks. Another half of patients will evenly take nitrendipine (10mg) or atenolol (25mg) first, and turn into nitrendipine/atenolol (5/10mg) next.

Arm	Type	Receives
Sequence 1	Experimental	Drug: Nitrendipine/Atenolol, Drug: Nitrendipine, Drug: AtenololOne pill of nitrendipine/atenolol combination (5/10mg) once daily for 6 weeks first, and followed by monotherapy for another 6 weeks, when patients will evenly assigned to one pill of nitrendipine (10mg) or one pill of atenolol (25mg) once daily.
Sequence 2	Experimental	Drug: Nitrendipine/Atenolol, Drug: Nitrendipine, Drug: AtenololMonotherapy for 6 weeks first, when patients will evenly assigned to one pill of nitrendipine (10mg) or one pill of atenolol (25mg) once daily, followed by one pill of nitrendipine/atenolol combination (5/10mg) once daily for another 6 weeks.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men or Women.
Aged 30-65 years.
Ambulatory systolic blood pressure ≥ 135 mmHg and/or diastolic blood pressure ≥ 85 mmHg.
Ambulatory daytime systolic blood pressure standard deviation (SD)≥13mmHg.
Never took antihypertensive drugs.

Key exclusion criteria (6 listed)

Under antihypertensive treatments.
Clinic systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg.
Contraindications to the treatment of drugs, including hypersensitivity reaction, bradycardia, asthma, etc.
Any cardiovascular disease except hypertension.
Suspected or confirmed secondary hypertension.

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
Nitrendipine/AtenololAlso: Nitrendipine and Atenolol TabletsNitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.	Drug	Sequence 1, Sequence 2
NitrendipineAlso: Nitrendipine TabletsNitrendipine 5mg, oral tablet, one pill daily.	Drug	Sequence 1, Sequence 2
AtenololAlso: Atenolol TabletsAtenolol 25mg, oral tablet, one pill daily.	Drug	Sequence 1, Sequence 2

Primary outcome

Ambulatory systolic blood pressure variability 1
Time frame: The first 6 weeks of treatment.
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).
Ambulatory systolic blood pressure variability 2
Time frame: The second 6 weeks of cross-over treatment.
Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).

4 secondary outcomes

Ambulatory diastolic blood pressure variability 1
Time frame: The first 6 weeks of treatment.
Ambulatory diastolic blood pressure variability 2
Time frame: The second 6 weeks of cross-over treatment.
Ambulatory blood pressure 1
Time frame: The first 6 weeks of treatment.
Ambulatory blood pressure 2
Time frame: The second 6 weeks of cross-over treatment.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Derived from this study: PubMed 39831760Xia JH, Cheng YB, Xu TY, Guo QH, Chan CM, Hu LX, Li Y, Wang JG. Effect of a calcium-channel blocker and beta-blocker combination on reading-to-reading blood pressure variability: a randomized crossover trial. Blood Press Monit. 2025 Apr 1;30(2):73-81. doi: 10.1097/MBP.0000000000000736. Epub 2024 Nov 26.

Related trials for Hypertension

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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.

Jiguang Wang, MD, PhD contact

+86-21-64370045 ext. 610911

jiguangw@163.com

Jiguang Wang, MD, PhD principal investigator

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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 Nitrendipine/Atenolol, Nitrendipine and Atenolol 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Apr 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?

Results are not available in the source record.

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

Contact Jiguang Wang, MD, PhD (+86-21-64370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory systolic blood pressure variability 1 (time frame: The first 6 weeks of treatment.). The study lists 2 primary outcomes in all. 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 NCT04931108, which also lists 1 linked publication.

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 Apr 2023.