Phase 4 N=186 Randomized Supportive Care

Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01508325 ↗

Enrolled (actual)

186

Serious AEs

1.1%

Results posted

May 2015

Primary outcome: Primary: Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment — 85.28; 85.68; -4.45; -3.39 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bisoprolol (Drug); Metoprolol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment	85.28; 85.68; -4.45; -3.39	—
PRIMARY Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment	75.67; 73.99; -8.04; -4.75	—
SECONDARY Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment	132.68; 133.24; -5.97; -5.12	—
SECONDARY Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12	132.76; 135.43; -5.40; -4.54; 84.60; 86.94	—
SECONDARY Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12	135.40; 138.31; -5.87; -5.16; 86.43; 88.86	—
SECONDARY Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12	125.16; 127.15; -4.81; -2.65; 79.14; 81.19	—
SECONDARY Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12	80.66; 78.94; -9.60; -3.85	—
SECONDARY Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12	67.73; 66.85; -4.72; -1.50	—
SECONDARY Change From Baseline in 24-hour Blood Pressure Variability at Week 12	10.89; 10.45; -0.12; 0.09; 12.68; 12.09	—
SECONDARY Blood Pressure Response Rate	86.67; 83.33	—
SECONDARY Heart Rate Response Rate	72.00; 55.56	—
SECONDARY Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12	77.45; 75.80; -8.46; -3.24	—

Summary

This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in subjects with mild to moderate primary hypertension.

Eligibility Criteria

Inclusion Criteria

Subjects aged: >=18 years and = =70 beats per minute (bpm)
Patients who have signed informed consent

Exclusion Criteria

Subjects with contraindications according to the China Summary of Product Characteristics (SmPCs) of both bisoprolol and metoprolol SR, such as acute heart failure, second or third degree atrioventricular block (without a pacemaker), sick sinus syndrome, symptomatic bradycardia or symptomatic hypotension, severe bronchial asthma or severe chronic obstructive pulmonary disease, metabolic acidosis, etc.
Moderate EH patients who have used anti-hypertension drugs
Secondary hypertension
Subjects with history of coronary heart disease
Chronic or acute heart failure
Cerebrovascular events within 6 months before screening
Impaired hepatic or renal function (according to local lab standard)
Other protocol defined exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01508325). 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.