NCT00544869已完成3 期
Phase 3 Open-label, Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure) - an Investigation of the Safety of Treatment Beyond 7 Days and the Effect of Dose Escalation to 30 mg
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
- 52
- 主要终点
- Body Weight
研究概览
简要总结
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) patients with extracellular volume expansion despite conventional diuretic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 treatment since 7 days prior to the commencement of study drug administration.
- •Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
- •A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
- •Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
- •Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
- •CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- •Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
- •Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
- •Subjects capable of giving informed consent to participate in the study of their own free will
排除标准
- •Heart failure patients with markedly fluctuating symptoms
- •Patients with an assisted circulation device
- •Patients with any of the following complications or symptoms:
- •Suspected decrease in circulatory blood flow ，
- •Hypertrophic cardiomyopathy (other than dilated phase)，
- •Cardiac valve disease with significant heart valve stenosis，
- •Hepatic coma
- •Patients who develop acute myocardial infarction within 30 days prior to the screening examination
- •Patients with a definite diagnosis of active myocarditis or amyloid cardiomyopathy
- •Subjects with any of the following complications or symptoms:
- •Poorly controlled diabetes melllitus，
- •Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- •Subjects with any of the following disease histories:
- •Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination in subjects without an implanted defibrillator，
- •Cerebrovascular disorder within 6 months prior to the screening examination (other than asymptomatic cerebral infarction)，
- •A history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride.
- •Subjects who are severely obese [body mass index (BMI, body weight (kg)/height (m)2] exceeding 35]
- •Subjects with systolic blood pressure in the decubitus position exceeding 90 mmHg
- •Subjects with any of the following abnormal laboratory values:
- •Total bilirubin > 3.0 mg/dL,
- •serum creatinine > 3.0 mg/dL,
- •serum sodium > 147 mEq/L,
- •serum potassium > 5.5 mEq/L
- •Patients who are unable to take oral medication
- •Female subjects who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant during the study period
- •Subjects who received any investigational drug other than OPC-41061 within 30 days prior to the screening examination
- •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
干预措施: OPC-41061 （Tolvaptan) (Drug)
结局指标
主要结局
Body Weight
时间窗: Baseline, Day 14 or at the time of final drug administration
The change of body weight from baseline at final observation
次要结局
未报告次要终点
研究者
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