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

Launched by MERCK KGAA, DARMSTADT, GERMANY · Jan 9, 2012

Keywords

ClinConnect Summary

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-week active treatment in subjects with mild to moderate essential hypertension (EH).

Secondary objectives:

1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several parameters at different times (Example: blood pressure, heart rate, their variability, etc...) after 12-week treatment from baseline among subjects with mild to moderate EH
2. To evaluate safety of the t...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects aged: \>=18 years and =\<70 years old
• • 2. 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.
• • 3. Clinic resting Heart Rate \>=70 beats per minute (bpm)
• • 4. Patients who have signed informed consent
• Exclusion Criteria:
• • 1. 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.
• • 2. Moderate EH patients who have used anti-hypertension drugs
• • 3. Secondary hypertension
• • 4. Subjects with history of coronary heart disease
• • 5. Chronic or acute heart failure
• • 6. Cerebrovascular events within 6 months before screening
• • 7. Impaired hepatic or renal function (according to local lab standard)
• • 8. Other protocol defined exclusion criteria could apply