Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Amlodipine; Bisoprolol

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