CClinicalTrials.gg
Sign In
Status unknownNCT04931108Updated Apr 14, 2023

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

A Phase 4 interventional study of Nitrendipine/Atenolol and Nitrendipine in Hypertension, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

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.
Read the 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.
02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • blood pressure variability
  • nitrendipine
  • atenolol
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 32 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • 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 · Drug: Nitrendipine · Drug: Atenolol

  • 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 · Drug: Nitrendipine · Drug: Atenolol

Interventions

  • DrugNitrendipine/Atenolol

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

    Also known as: Nitrendipine and Atenolol Tablets

  • DrugNitrendipine

    Nitrendipine 5mg, oral tablet, one pill daily.

    Also known as: Nitrendipine Tablets

  • DrugAtenolol

    Atenolol 25mg, oral tablet, one pill daily.

    Also known as: Atenolol Tablets

06

What researchers measure

Primary outcomes

  1. Ambulatory systolic blood pressure variability 1

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

    Time frame: The first 6 weeks of treatment.

  2. Ambulatory systolic blood pressure variability 2

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

    Time frame: The second 6 weeks of cross-over treatment.

Secondary outcomes

  1. Ambulatory diastolic blood pressure variability 1

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

    Time frame: The first 6 weeks of treatment.

  2. Ambulatory diastolic blood pressure variability 2

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

    Time frame: The second 6 weeks of cross-over treatment.

  3. Ambulatory blood pressure 1

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

    Time frame: The first 6 weeks of treatment.

  4. Ambulatory blood pressure 2

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

    Time frame: The second 6 weeks of cross-over treatment.

07

Study locations

1 of 1 sites recruiting
  • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200025, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04931108
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Ji-Guang Wang (Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jun 18, 2021
Start date
Sep 27, 2021
Primary completion
Jun 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Apr 14, 2023

Study contacts

Jiguang Wang, MD, PhD
Contact
jiguangw@163.com
+86-21-64370045 ext. 610911
Jiguang Wang, MD, PhD
principal investigator · Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Shanghai Jiao Tong University School of Medicine

Start the discussion