NCT00071331已完成3 期
Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure
Otsuka Pharmaceutical Development & Commercialization, Inc.630 个研究点 分布在 2 个国家目标入组 3,600 人开始时间: 2003年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,600
- 试验地点
- 630
研究概览
简要总结
The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).
详细描述
Study Design: Multicenter, randomized, double-blind, placebo-controlled
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
- Double
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 greater than or equal to 18 years.
- •Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.
- •The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea.
- •NYHA Class III or IV at the time of hospitalization.
- •Left Ventricular Ejection Fraction < = 40% within one year.
- •Exclusion Criteria
- •Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
- •Positive urine pregnancy test.
- •Inability to provide written informed consent.
- •Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
- •Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
- •Subjects who are on cardiac mechanical support.
- •History of bi-ventricular pacer placement within the last 60 days.
- •Co-morbid condition with an expected survival less than six months.
- •Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
- •History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
- •History of a cerebrovascular accident within the last 30 days.
- •Hemodynamically significant uncorrected primary cardiac valvular disease.
- •Hypertrophic cardiomyopathy (obstructive or non-obstructive).
- •CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
- •Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
- •History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
- •History of poorly controlled diabetes mellitus.
- •Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI >
- •Supine systolic arterial blood pressure < 90 mmHg.
- •Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L.
- •Serum potassium > 5.5 mEq/L or > 5.5 mmol/L.
- •Hemoglobin < 9 g/dL or < 90 g/L.
- •History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
- •History of drug or medication abuse within the past year, or current alcohol abuse.
- •Inability to take oral medications.
- •Participation in another clinical drug or device trial within the past 30 days.
- •Previous participation in this or any other tolvaptan clinical trial.
排除标准
- 未提供
研究者
研究点 (630)
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