jRCT1080221581未知4 期
A multi-center,_double-blind,_pararel-group comparison trial to investigate the effect of short-term administration of tolvaptan on mid- to long-term prognosis of heart failure patients (Phase_4 study)
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Assessment of events over 26 weeks
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double-blind controlled pararel-arm Study
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Patients from whom informed consent has been properly obtained in writing prior to start of the trial
- •Patients who have been clinically diagnosed with heart failure
- •Patients with any of the following conditions or symptoms: lower limb edema, dyspnea, jugular venous distension, hepatomegaly, pulmonary rales, third heart sound, or pulmonary congestion
- •Patients who have been receiving loop diuretics, thiazide diuretics, or anti-aldosterone diuretics
- •Male or female patients of age 20 to 85 years inclusive (at time of informed consent)
- •Patients who, together with their partner(s), are able to use an appropriate method of contraception until 3 months after final trial drug administration
- •Patients who are able to be hospitalized at the trial site for at least 7 days from the start of trial drug administration
排除标准
- •Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
- •Patients with anuria
- •Patients who cannot sense thirst or who have difficulty with fluid intake
- •Patients with hypernatremia (serum sodium concentration > institutional upper limit of normal)
- •Female patients who are pregnant, possibly pregnant, or nursing
- •Patients judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial due to any of the following conditions or symptoms:
- •Hyponatremia (serum sodium concentration < 125 mEq/L)
- •Serious coronary artery disease or cerebrovascular disease
- •Hyperkalemia
- •Severe renal disorder
- •Poorly controlled diabetes mellitus
- •Severe hepatic disease
- •Impaired urinary excretion due to urinary stenosis, calculus, or tumor
- •Cardiac valve disease with significant heart valve stenosis
- •Malignant tumor of unfavorable prognosis
- •Patients with suspected hypovolemia
- •Patients with an implanted circulatory support device
- •Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
- •Patients who participated in any other clinical trial or postmarketing clinical trial within 30 days prior to the date of informed consent for the present trial
- •Patients who received tolvaptan within 26 weeks prior to the date of informed consent
- •Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
结局指标
主要结局
Assessment of events over 26 weeks
时间窗: Week 26
Adverse events, serum sodium concentration, clinical laboratory tests, vital signs, 12-lead ECG, M-mode echocardiography, and mortality at Week 26
Change from baseline
Body weight, congenitive findings, cardiothoracic ratio, pulmonary congestion, New York Heart Association (NYHA) Classification, plasma brain natriuretic peptide (BNP) concentration
次要结局
未报告次要终点
研究者
相似试验
未知
4 期
A multi-center,_double-blind,_pararel-group comparison phase 4 trial to investigate the effect of tolvaptan on mid- to long-term prognosis of heart failure patientsVolume overload in heart failure that does not respond adequately to other diuretics (e.g., loop diuretics)JPRN-jRCT1080221581Otsuka Pharmaceutical Co., Ltd.100
已完成
3 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (16 to 70 years old) with Partial Onset Seizures.10029305epilepsyNL-OMON31126CB Pharma24
进行中（未招募）
1 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures.Estudio multicentrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos: evaluacion de la eficacia y la seguridad del brivaracetam en sujetos (edad >= 16 a 70 anos) con crisis de inicio parcial. - POS Phase 3Partial Onset SeizuresCrisis de inicio parcialMedDRA version: 9.1Level: LLTClassification code 10015037Term: EpilepsyEUCTR2006-006344-59-ESCB Pharma399
进行中（未招募）
不适用
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3EUCTR2006-006344-59-NLCB Pharma500
进行中（未招募）
1 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3Partial Onset SeizuresMedDRA version: 9.1Level: LLTClassification code 10015037Term: EpilepsyEUCTR2006-006344-59-FRCB Pharma399