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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd., China
• Treatments: Atenolol; Bisoprolol

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