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
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Bisoprolol; Atenolol
Intervention description: Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.; Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.
Intervention MeSH terms: Atenolol; Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension; Bisoprolol; Atenolol

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