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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: Nitrendipine/Atenolol; Drug: Nitrendipine; Drug: Atenolol

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jiguang Wang, MD, PhD; Phone Number: 610911 86-21-64370045; Email: jiguangw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Ambulatory blood pressure 1	Including ambulatory blood pressure over 24 hours, daytime and nighttime.	The first 6 weeks of treatment.
Ambulatory blood pressure 2	Including ambulatory blood pressure over 24 hours, daytime and nighttime.	The second 6 weeks of cross-over treatment.

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiguang Wang, MD, PhD, Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: blood pressure variability; nitrendipine; atenolol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Atenolol; Nitrendipine
• Other Study ID Numbers: NAC-BPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No