NCT01977794已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bisoprolol failed group
Experimental
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
干预措施: Bisoprolol/Amlodipine (Bisoprolol failed group) (Drug)
Amlodipine failed group
Experimental
Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion will be randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet.
干预措施: Bisoprolol/Amlodipine (Amlodipine failed group) (Drug)
结局指标
主要结局
Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline
时间窗: Baseline, Week 18
Baseline was defined as the latest SBP under monotherapy.
次要结局
- 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)
- Change From Baseline in Diastolic Blood Pressure (DBP) 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))
研究者
研究点 (1)
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