A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

NCT01251146 | Completed Phase 4 Results

• 1 other identifier: EMR200006-515
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension.

Conditions

Hypertension

Keywords

Hypertension; Bisoprolol; Atenolol

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal

  Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).

  Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)

• Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up

  Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.

  Baseline and end of follow-up (Week 4 or Week 6 or Week 8)

Secondary Outcomes (6)

• Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up

  Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)

• Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up

  Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)

• Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment

  Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)

• Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6

  Attainment of heart rate goal (Week 2 or Week 4 or Week 6)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)

Study Arms (2)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Atenolol

ACTIVE COMPARATOR

Drug: Atenolol

Interventions

Bisoprolol DRUG

Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.

Also known as: Concor®

Bisoprolol

Atenolol DRUG

Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.

Atenolol

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 25-65 years
• Subjects with essential hypertension (EH)
• Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
• Subjects with normal sinus rhythm
• Subjects with resting heart rate (RHR) greater than 70 bpm
• Subjects who give written informed consent

You may not qualify if:

• Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
• Subjects with bradyarrhythmia/hypotension
• Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association \[NYHA\] Class III - IV)
• Subjects with uncontrolled diabetes mellitus (DM)
• Subjects with bronchial asthma
• Subjects with gastro-intestinal ulcer or skin ulcer
• Subjects with liver dysfunction/renal impairment
• Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
• Subjects with glaucoma
• Subjects with known allergic/intolerance to beta-blocker
• Pregnant or lactating women
• Subjects who had participated in another clinical study within the last 3 months
• Subjects who have legal incapacity or limited legal capacity

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (2)

Beijing Shi Jingshan Hospital

Beijing, China

Location

Shanghai Institute of Hypertension

Shanghai, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Bisoprolol; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Gao Pingjin, Prof.

  Shanghai Institute of Hypertension

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 8, 2017
• Results First Posted: November 30, 2012

Record last verified: 2017-01

Locations

CN (2)