Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Bisoprolol; Metoprolol
Intervention description: Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.; Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
Intervention MeSH terms: Metoprolol; Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bisoprolol; Hypertension; Blood pressure; Heart rate

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:

          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