This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose
combination (FDC) of bisoprolol and amlodipine in hypertensive subjects.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Essential hypertension not controlled at 5 mg bisoprolol or 5 mg amlodipine at least
12 weeks (definition of not controlled: SBP greater than or equal to (>=) 140
millimeter of mercury (mmHg) with or without DBP >= 90 mmHg)
- Male or female subjects >=18 years of age, without limitation on race
- Medically accepted effective contraception if procreative potential exists
(applicable for both male and female subjects until at least 90 days after the last
dose of trial treatment)
- Subjects who have signed the informed consent form before any trial related
assessment
Exclusion Criteria:
- General contraindications of beta-blockers and/or calcium channel blockers
- Previous and concurrent acute heart failure or during episodes of heart failure
decompensation requiring intravenous inotropic therapy
- Concurrent cardiogenic shock
- Previous and concurrent second or third degree atrioventricular (AV) block
(without a pacemaker)
- Previous and concurrent sick sinus syndrome
- Previous and concurrent sinoatrial block
- Concurrent symptomatic bradycardia
- Concurrent symptomatic hypotension
- Previous and concurrent severe bronchial asthma or chronic obstructive pulmonary
diseases
- Previous and concurrent severe peripheral arterial occlusive diseases and
Raynaud's syndrome
- Untreated pheochromocytoma
- Concurrent metabolic acidosis
- Known hypersensitivity to bisoprolol, amlodipine, dihydropyridine derivates or
to any of the excipients
- Seated pulse rate less than 60 beats per minute (bpm) at screening
- Any other anti-hypertensive drugs (other than bisoprolol and amlodipine) are used
within 4 weeks prior to the screening visit
- Use of any enzyme-modifying drugs acting on cytochrome P450 (CYP) 3A4 enzymes via
inhibition (such as ketoconazole, itraconazole, ritonavir) or induction (such as
rifampicin or hypericum perforatum) within 28 days before Day 1 of the trial
- Other significant disease that in the Investigator's opinion that would exclude the
subject from the trial, such as uncontrolled diabetes mellitus, severe liver and/or
kidney dysfunction, decompensated cardiac failure
- Any other condition or therapy which in the Investigator's opinion would pose a risk
to the subject or interfere with the trial objectives
- Concurrent alcohol and/or drug abuse
- Known hypersensitivity to the trial treatments
- Pregnancy and lactation period. All female subjects with reproductive potential must
have a negative pregnancy serum test within the 7 days prior to enrollment
- Known lack of subject compliance
- Legal incapacity or limited legal capacity
- Participation in another clinical trial within the previous 30 days
- Persons directly involved in the execution of the protocol