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

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ClinicalTrials.gov Identifier: NCT01977794
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : August 11, 2016
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief 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).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Bisoprolol/Amlodipine (Bisoprolol failed group) Drug: Bisoprolol/Amlodipine (Amlodipine failed group) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Trial of Concor AM, a Fixed Dose Combination of Bisoprolol and Amlodipine, on the Treatment of Essential Hypertensive Patients Whose Blood Pressure is Not Well Controlled by Monotherapy of Bisoprolol 5mg or Amlodipine 5mg
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: Bisoprolol failed group
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
Drug: Bisoprolol/Amlodipine (Bisoprolol failed group)
Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).
Other Name: Concor AM

Experimental: Amlodipine failed group
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet.
Drug: Bisoprolol/Amlodipine (Amlodipine failed group)
Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).
Other Name: Concor AM




Primary Outcome Measures :
  1. Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline [ Time Frame: Baseline, Week 18 ]
    Baseline was defined as the latest SBP under monotherapy.


Secondary Outcome Measures :
  1. Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment [ Time Frame: Baseline, Week 18 ]
    Baseline was defined as the latest DBP before study treatment administration.

  2. Percentage of Subjects With Controlled Blood Pressure [ Time Frame: Baseline up to Week 18 ]
  3. Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment [ Time Frame: Baseline, Week 18 ]
    Baseline was defined as the latest HR before study treatment administration

  4. Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death [ Time Frame: Baseline up to Day 127 (end of trial) ]
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977794


Locations
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Germany
Please contact the Merck KGaA Communication Center located in
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical responsible Merck KGaA, Darmstadt, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01977794     History of Changes
Other Study ID Numbers: 200006-524
First Posted: November 7, 2013    Key Record Dates
Results First Posted: August 11, 2016
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by Merck KGaA, Darmstadt, Germany:
Bisoprolol
Amlodipine
Fixed dose combination (FDC)
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP)

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Bisoprolol
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents