Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension
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
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
August 11, 2016
CompletedJanuary 30, 2017
January 1, 2017
1 year
October 31, 2013
July 4, 2016
January 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
Baseline was defined as the latest SBP under monotherapy.
Baseline, Week 18
Secondary Outcomes (4)
Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment
Baseline, Week 18
Percentage of Subjects With Controlled Blood Pressure
Baseline up to Week 18
Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment
Baseline, Week 18
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death
Baseline up to Day 127 (end of trial)
Study Arms (2)
Bisoprolol failed group
EXPERIMENTALSubjects who failed monotherapy with bisoprolol 5 milligram (mg) before trial inclusion will be randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet
Amlodipine failed group
EXPERIMENTALSubjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Please contact the Merck KGaA Communication Center located in
Darmstadt, Germany
Related Publications (1)
Gottwald-Hostalek U, Li L, Montenegro P. Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure. Curr Med Res Opin. 2016 Oct;32(10):1735-1743. doi: 10.1080/03007995.2016.1205573. Epub 2016 Jul 4.
PMID: 27334671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 7, 2013
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
January 30, 2017
Results First Posted
August 11, 2016
Record last verified: 2017-01