Back to resultsA 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
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bisoprolol
Atenolol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Bisoprolol, Atenolol
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Shi Jingshan Hospital
- Shanghai Institute of Hypertension
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bisoprolol
Atenolol
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
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
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition
Number of Participants Compliant With Study Treatment
Participants compliant with study treatment were the participants who have completed the study treatment regimen.
Full Information
NCT ID
NCT01251146
First Posted
November 30, 2010
Last Updated
January 25, 2017
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China
1. Study Identification
Unique Protocol Identification Number
NCT01251146
Brief Title
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
Official Title
Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Bisoprolol, Atenolol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bisoprolol
Arm Type
Experimental
Arm Title
Atenolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Other Intervention Name(s)
Concor®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
Description
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).
Time Frame
Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Title
Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
Description
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.
Time Frame
Baseline and end of follow-up (Week 4 or Week 6 or Week 8)
Secondary Outcome Measure Information:
Title
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
Description
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame
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)
Title
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
Description
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame
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)
Title
Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
Description
Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame
Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Title
Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
Description
Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Time Frame
Attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition
Time Frame
Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Title
Number of Participants Compliant With Study Treatment
Description
Participants compliant with study treatment were the participants who have completed the study treatment regimen.
Time Frame
Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao Pingjin, Prof.
Organizational Affiliation
Shanghai Institute of Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Shi Jingshan Hospital
City
Beijing
Country
China
Facility Name
Shanghai Institute of Hypertension
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
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
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