NCT00525265已完成3 期
A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)
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
- 20
- 主要终点
- Body Weight
研究概览
简要总结
To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
- •Subjects able to receive a daily regular dosage of furosemide at 40-mg to 80-mg from the observation period until the end-of-treatment examination.
- •CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- •Male or female subjects between the age of 20 and 85, inclusive.
- •Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination
- •Subjects capable of giving informed consent to participate in the study of their own free will.
排除标准
- •Subjects with heart failure with markedly fluctuating symptoms.
- •Subjects with an assisted circulation device.
- •Subjects with any of the following complications or symptoms:(1)Suspected decrease in circulatory blood flow,(2)Hypertrophic cardiomyopathy (other than dilated phase),(3)Cardiac valve disease with significant heart valve stenosis,(4)Hepatic coma.
- •Subjects who develop acute myocardial infarction within 30 days prior to the screening examination.
- •Subjects with well-defined diagnosis of active myocarditis or amyloid cardiomyopathy.
- •Subjects with any of the following complications or symptoms:(1)Diabetes mellitus with poorly controlled blood glucose,(2)Anuria,(3)Urination impaired due to urinary tract stricture,urinary calculus,tumor in urinary tract,or other cause.
- •Subjects with a history of any of the following diseases:(1)Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in patients without an implanted defibrillator,(2)Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction),(3)Hypersensitivity or idiosyncratic reaction to benzazepine derivatives.
- •Subjects who are morbidly obese (body mass index exceeding 35).
- •Subjects with systolic blood pressure in the decubitus position below 90 mmHg.
- •Subjects with any of the following abnormal laboratory values:(1)Total bilirubin > 3.0 mg/dL,(2) serum creatinine > 3.0 mg/dL,(3)serum sodium > 147 mEq/L,(4)serum potassium > 5.5 mEq/L.
- •Subjects who are unable to take oral medication.
- •Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant.
- •Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination.
- •Subjects who previously participated in this or any other study of OPC-41061 and received OPC-
- •Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study.
研究组 & 干预措施
1
Experimental
OPC-41061
干预措施: OPC-41061(Tolvaptan) (Drug)
2
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Body Weight
时间窗: Baseline, at the time of final trial drug administration
The body weight change from baseline at the time of final trial drug administration
次要结局
未报告次要终点
研究者
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未知
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