JPRN-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)
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1) Patients from whom informed consent has been properly obtained in writing prior to start of the trial
- •2) Patients who have been clinically diagnosed with heart failure
- •3) 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
- •4) Patients who have been receiving loop diuretics, thiazide diuretics, or anti-aldosterone diuretics
- •5) Male or female patients of age 20 to 85 years inclusive (at time of informed consent)
- •6) Patients who, together with their partner(s), are able to use an appropriate method of contraception until 3 months after final trial drug administration
- •7) 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
- •1) Patients with a history of hypersensitivity to any ingredient of the drug or to tolvaptan analogues (e.g., mozavaptan hydrochloride)
- •2) Patients with anuria
- •3) Patients who cannot sense thirst or who have difficulty with fluid intake
- •4) Patients with hypernatremia (serum sodium concentration > institutional upper limit of normal)
- •5) Female patients who are pregnant, possibly pregnant, or nursing
- •6) 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
- •7) Patients with suspected hypovolemia
- •8) Patients with an implanted circulatory support device
- •9) Patients in whom acute cardiac infarction occurred within 30 days prior to the screening examination
- •10) 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
- •11) Patients who received tolvaptan within 26 weeks prior to the date of informed consent
- •12) Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
研究者
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