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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Atenolol

Drug: Bisoprolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01251146

EMR200006-515

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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