fixed dose combination of bisoprolol and amlodipine in the treatment of hypertension

Conditions: Hypertension

Summary: this is a randomized, comparative phase 3 trial to investigate the efficacy of fixed dose combination (fdc) of bisoprolol and amlodipine in hypertensive subjects (superiority of fdc over monotherapies).


Eligibility criteria:
inclusion criteria: * essential hypertension not controlled at 5 mg bisoprolol or 5 mg amlodipine at least 4 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

Keywords: bisoprolol amlodipine fixed dose combination (fdc) systolic blood pressure (sbp) diastolic blood pressure (dbp)