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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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Bisoprolol (Drug); Atenolol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Gao Pingjin, Prof., Principal Investigator, Affiliation: Shanghai Institute of Hypertension

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.

Clinical Details

Official title: Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

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

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

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

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

Number of Participants Compliant With Study Treatment

Eligibility

Minimum age: 25 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Beijing Shi Jingshan Hospital, Beijing, China

Shanghai Institute of Hypertension, Shanghai, China

Additional Information

Starting date: November 2010
Last updated: January 20, 2014

Page last updated: August 23, 2015

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