Status:
COMPLETED
Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Co., Ltd., China
Conditions:
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Primary objectives: To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-wee...
Eligibility Criteria
Inclusion
- Subjects aged: \>=18 years and =\<70 years old
- EH who are suitable for mono-therapy, either mild to moderate EH patients who have not been treated with anti-hypertension drugs, or mild EH subjects who have taken anti-hypertension drug.
- Clinic resting Heart Rate \>=70 beats per minute (bpm)
- Patients who have signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01508325
Start Date
December 1 2011
End Date
April 1 2014
Last Update
May 13 2015
Active Locations (1)
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1
Merck Serono Investigational Site
Changsha, China