Status:
COMPLETED
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
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Co., Ltd., China
Conditions:
Hypertension
Eligibility:
All Genders
25-65 years
Phase:
PHASE4
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) activ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01251146
Start Date
November 1 2010
End Date
February 1 2012
Last Update
March 8 2017
Active Locations (2)
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1
Beijing Shi Jingshan Hospital
Beijing, China
2
Shanghai Institute of Hypertension
Shanghai, China