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

Launched by MERCK KGAA, DARMSTADT, GERMANY · Oct 31, 2013

Keywords

ClinConnect Summary

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Gender

ALL

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