NCT00132886已完成2 期
Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure
Otsuka Pharmaceutical Development & Commercialization, Inc.62 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2004年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 62
- 主要终点
- Change in heart pressures (PCWP) at 3 to 8 hours post-dose
研究概览
简要总结
This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
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
- •Diagnosed with Class III or IV heart failure for at least 3 months
- •Left ventricular ejection fraction less than or equal to 40%
- •Currently being treated for heart failure with standard therapies for at least one month
排除标准
- •Women who are pregnant or breastfeeding
- •Inability to take oral medications
- •Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
- •Hypertrophic obstructive cardiomyopathy
- •Severe obstructive pulmonary disease
- •Significant renal impairment
- •Significant uncorrected valvular or congenital heart disease
结局指标
主要结局
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
次要结局
- Cmax, tmax, and AUC 12h of tolvaptan in plasma
- Change in urine output and free water clearance
- Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
- Adverse events, vital signs and clinical labs
- Change from baseline in urine osmolality
研究者
研究点 (62)
Loading locations...
相似试验
已完成
1 期
Effect of Imeglimin on QT/QTc Intervals in Healthy SubjectsQt Interval, Variation inNCT02924337Poxel SA55
已完成
4 期
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure PatientsHeart FailureNCT01439009Otsuka Pharmaceutical Co., Ltd.100
已完成
2 期
Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel ResectionEnhanced Recovery After SurgeryNCT04742907Tsumura USA402
已完成
2 期
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch PollenAllergic RhinitisNCT02943720Anergis421
已完成
3 期
To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus InfectionInfluenzaNCT05474755Jiangxi Qingfeng Pharmaceutical Co. Ltd.591