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

NCT04931108 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-04-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nitrendipine/Atenolol

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

DRUG

Nitrendipine

Nitrendipine 5mg, oral tablet, one pill daily.

DRUG

Atenolol

Atenolol 25mg, oral tablet, one pill daily.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiguang Wang, MD, PhD · Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04931108 on ClinicalTrials.gov