Phase 4 N=177 Randomized Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01251146 ↗

Enrolled (actual)

177

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal — 7.78; 7.92; 3.27; 2.88 millisecond per millimeter of mercury

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bisoprolol (Drug); Atenolol (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal	7.78; 7.92; 3.27; 2.88	—
PRIMARY Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up	4.08; 3.31	—
SECONDARY 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	261.80; 322.09; 90.04; 26.14; 89.40; -22.00	—
SECONDARY 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	2.16; 2.40; -0.70; -0.90; -0.69; -1.15	—
SECONDARY Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment	72; 72; 7; 6; 1; 0	—
SECONDARY Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6	83.72; 79.12; 91.86; 85.71; 93.02; 85.71	—
SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	6; 6; 0; 0	—
SECONDARY Number of Participants Compliant With Study Treatment	83; 81	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01251146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.