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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931108
• Other study ID #: NAC-BPV
• Status: Recruiting
• Phase: Phase 4
• Start date: September 27, 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiguang Wang, MD, PhD
• Phone: +86-21-64370045
• Email: jiguangw[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

1. Study name: The effect of Nitrendipine/Atenolol combination on blood pressure variability of patients with Grade 1 hypertension compared with nitrendipine or atenolol monotherapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory systolic blood pressure variability 1	Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).	The first 6 weeks of treatment.
Primary	Ambulatory systolic blood pressure variability 2	Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).	The second 6 weeks of cross-over treatment.
Secondary	Ambulatory diastolic blood pressure variability 1	Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).	The first 6 weeks of treatment.
Secondary	Ambulatory diastolic blood pressure variability 2	Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).	The second 6 weeks of cross-over treatment.
Secondary	Ambulatory blood pressure 1	Including ambulatory blood pressure over 24 hours, daytime and nighttime.	The first 6 weeks of treatment.
Secondary	Ambulatory blood pressure 2	Including ambulatory blood pressure over 24 hours, daytime and nighttime.	The second 6 weeks of cross-over treatment.