NCT04931108

Brief Summary

  1. 1.Study name: The Effect of Nitrendipine/Atenolol Combination on Blood Pressure Variability.
  2. 2.Medicine: Nitrendipine/Atenolol; Nitrendipine; Atenolol.
  3. 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. 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. 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. 6.Study population: Men and Women aged 30-65 years (n=32) meeting the inclusion/exclusion criteria.
  7. 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. 8.Follow up: 14 weeks.
  9. 9.Sample size: a total of 32 patients should be enrolled.
  10. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

May 27, 2021

Last Update Submit

April 11, 2023

Conditions

Hypertension

Keywords

blood pressure variabilitynitrendipineatenolol

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (4)

  • Ambulatory diastolic blood pressure variability 1

    The first 6 weeks of treatment.

  • Ambulatory diastolic blood pressure variability 2

    The second 6 weeks of cross-over treatment.

  • Ambulatory blood pressure 1

    The first 6 weeks of treatment.

  • Ambulatory blood pressure 2

    The second 6 weeks of cross-over treatment.

Study Arms (2)

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.

Drug: Nitrendipine/AtenololDrug: NitrendipineDrug: 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.

Drug: Nitrendipine/AtenololDrug: NitrendipineDrug: Atenolol

Interventions

Nitrendipine/AtenololDRUG

Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.

Also known as: Nitrendipine and Atenolol Tablets
Sequence 1Sequence 2
NitrendipineDRUG

Nitrendipine 5mg, oral tablet, one pill daily.

Also known as: Nitrendipine Tablets
Sequence 1Sequence 2
AtenololDRUG

Atenolol 25mg, oral tablet, one pill daily.

Also known as: Atenolol Tablets
Sequence 1Sequence 2

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39831760DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

NitrendipineAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Jiguang Wang, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045jiguangw@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Shanghai Institute of Hypertension

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 18, 2021

Study Start

September 27, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

CN(1)