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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Bisoprolol/Amlodipine (Amlodipine failed group); Drug: Bisoprolol/Amlodipine (Bisoprolol failed group)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01977794

200006-524

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Bisoprolol failed group

Experimental group

Description:

Subjects who failed monotherapy with bisoprolol 5 milligram (mg) before trial inclusion will be randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet

Treatment:

Drug: Bisoprolol/Amlodipine (Bisoprolol failed group)

Amlodipine failed group

Experimental group

Description:

Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet.

Treatment:

Drug: Bisoprolol/Amlodipine (Amlodipine failed group)