NCT01756430已完成3 期
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension
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
- 238
- 试验地点
- 1
- 主要终点
- Mean Sitting Diastolic Blood Pressure (MSDBP)
研究概览
简要总结
The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension
详细描述
- In patients with Essential hypertension to evaluate the efficacy and safety of Carvedilol SR (32mg, 64mg) or Carvedilol IR (25mg QD, 25mg BID) during 8 weeks.
- This study is consist of placebo run-in period(2~4 weeks_single blind) and treatment period(8 weeks_double blind).
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
- Triple (Participant, Care Provider, Investigator)
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
- •age 18 years or older
- •at the screening visit(visit 1)
- •antihypertensive drugs not taking: 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- •antihypertensive drugs taking: mean sitDBP ≤ 104mmHg and mean sitSBP < 180mmHg
- •at the randomization visit(visit 2): 90mmHg ≤ mean sitDBP ≤ 109mmHg and mean sitSBP < 180mmHg
- •willing and able to provide written informed consent
排除标准
- •At Screening, difference in measured blood pressure of the selected arm(sitDBP ≥ 10mmHg or sitSBP ≥ 20mmHg)
- •known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- •Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c > 9%)
- •Corresponding to the following
- •has severe heart disease(Heart failure NYHA functional class 3, 4)
- •ischaemic heart diseases within 6 months (unstable angina or myocardial infarction)
- •myocardiopathy
- •Cor pulmonale
- •aortic stenosis , aortic valvular stenosis , mitral stenosis
- •abnormality of the conduction system as 2nd degree AV block, Complete AV block, Sick Sinus Syndrome, Sinus Block(In particular, pulse <50beats / min)
- •has heart attack with complication.
- •has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- •has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease.
- •Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
- •Fluid retention or overload to required intravenous inotropes.
- •known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal microaneurysms and so on within 6 months)
- •defined by the following laboratory parameters:
- •hepatic dysfunction(AST/ALT ≥ UNL X 3)
- •renal dysfunction(serum creatinine ≥ UNL X 2)
- •any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
- •history of drug or alcohol dependency within 6 months
- •premenopausal women(last menstruation < 12 months) not using adequate contraception, pregnant or breast-feeding
- •chronic inflammatory status need to treatment
- •known hypersensitivity related to carvedilol
- •history of malignancy including leukemia and lymphoma within the past 5 years
- •administration of other study drugs within 28 days prior to the first IP administration
- •in investigator's judgment
研究组 & 干预措施
Carvedilol SR 32mg, 64mg
Experimental
•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.
干预措施: Carvedilol SR 32mg, QD (Drug)
Carvedilol SR 32mg, 64mg
Experimental
•Carvedilol SR 32mg QD for first 4 weeks and Carvedilol SR 64mg QD for following 4 weeks.
干预措施: Carvedilol SR 64mg, QD (Drug)
Carvedilol IR 25mg
Active Comparator
•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.
干预措施: Carvedilol IR 25mg, QD (Drug)
Carvedilol IR 25mg
Active Comparator
•Carvedilol IR 25mg QD for first 4 weeks and Carvedilol IR 25mg BID for following 4 weeks.
干预措施: Carvedilol IR 25mg, BID (Drug)
结局指标
主要结局
Mean Sitting Diastolic Blood Pressure (MSDBP)
时间窗: After 4 and 8 weeks of treatment
次要结局
- Mean Sitting systolic Blood Pressure (MSSBP)(After 4 weeks and 8 weeks of treatment)
- Control Rate(After 8 weeks of treatment)
- Response Rate(After 8 weeks of treatment)
研究者
研究点 (1)
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