The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
NCT ID: NCT04931108
Last Updated: 2023-04-14
Study Results
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Basic Information
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UNKNOWN
PHASE4
32 participants
INTERVENTIONAL
2021-09-27
2023-06-30
Brief Summary
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2. Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol.
3. 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.
4. Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
5. 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).
6. Study population: Men and Women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria.
7. 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.
8. Follow up: 14 weeks.
9. Sample size: a total of 32 patients should be enrolled.
10. 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.
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Detailed Description
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2. Medicine: Nitrendipine/Atenolol (5/10mg tablet); Nitrendipine (10mg tablet); Atenolol (25mg tablet)
3. 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.
4. Objective: To evaluate the effect of nitrendipine/atenolol on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.
5. 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).
6. 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.
7. 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.
8. 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.
9. Sample size: a total of 32 patients should be enrolled.
10. 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.
11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
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.
Nitrendipine/Atenolol
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
Nitrendipine
Nitrendipine 5mg, oral tablet, one pill daily.
Atenolol
Atenolol 25mg, oral tablet, one pill daily.
Sequence 2
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.
Nitrendipine/Atenolol
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
Nitrendipine
Nitrendipine 5mg, oral tablet, one pill daily.
Atenolol
Atenolol 25mg, oral tablet, one pill daily.
Interventions
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Nitrendipine/Atenolol
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
Nitrendipine
Nitrendipine 5mg, oral tablet, one pill daily.
Atenolol
Atenolol 25mg, oral tablet, one pill daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
30 Years
65 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Ji-Guang Wang
Director of the Shanghai Institute of Hypertension
Principal Investigators
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Jiguang Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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NAC-BPV
Identifier Type: -
Identifier Source: org_study_id
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