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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04931108
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability of Patients With Grade 1 Hypertension Compared With Nitrendipine or Atenolol Monotherapy.
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Nitrendipine/Atenolol
Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
Other Names:
  • Nitrendipine and Atenolol Tablets

    • Drug: Nitrendipine
    Nitrendipine 5mg, oral tablet, one pill daily.
    Other Names:
  • Nitrendipine Tablets

    • Drug: Atenolol
    Atenolol 25mg, oral tablet, one pill daily.
    Other Names:
  • Atenolol Tablets

    		•
    Experimental: 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.

    Drug: Nitrendipine/Atenolol
    Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
    Other Names:
  • Nitrendipine and Atenolol Tablets

    • Drug: Nitrendipine
    Nitrendipine 5mg, oral tablet, one pill daily.
    Other Names:
  • Nitrendipine Tablets

    • Drug: Atenolol
    Atenolol 25mg, oral tablet, one pill daily.
    Other Names:
  • Atenolol Tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ambulatory systolic blood pressure variability 1 [The first 6 weeks of treatment.]

      Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).

    2. Ambulatory systolic blood pressure variability 2 [The second 6 weeks of cross-over treatment.]

      Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).

    Secondary Outcome Measures

    1. Ambulatory diastolic blood pressure variability 1 [The first 6 weeks of treatment.]

      Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).

    2. Ambulatory diastolic blood pressure variability 2 [The second 6 weeks of cross-over treatment.]

      Including the average real variability (ARV), the coefficient of variation (CV),and the standard deviation (SD).

    3. Ambulatory blood pressure 1 [The first 6 weeks of treatment.]

      Including ambulatory blood pressure over 24 hours, daytime and nighttime.

    4. Ambulatory blood pressure 2 [The second 6 weeks of cross-over treatment.]

      Including ambulatory blood pressure over 24 hours, daytime and nighttime.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji-Guang Wang, Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04931108
    Other Study ID Numbers:
    • NAC-BPV
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ji-Guang Wang, Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine
    blood pressure variability
    nitrendipine
    atenolol
    Additional relevant MeSH terms:
    Hypertension
    Atenolol
    Nitrendipine

    Study Results

    No Results Posted as of Jun 18, 2021