NCT00578695已完成3 期
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
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
- 652
- 试验地点
- 24
- 主要终点
- To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.
排除标准
- 未提供
研究组 & 干预措施
Active
Experimental
Lixivaptan
干预措施: lixivaptan (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated.
时间窗: 60 days
次要结局
未报告次要终点
研究者
研究点 (24)
Loading locations...
相似试验
进行中（未招募）
3 期
A clinical trial to study the effect of lixivaptan in the treatment of hyponatremia in NYHA Class III/IV Cardiac PatientsCTRI/2009/091/000319Cardiokine Biopharma650
进行中（未招募）
1 期
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluatioHyponatremiaEUCTR2006-002567-62-SKCardiokine Biopharma, LLC650
进行中（未招募）
不适用
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluatioMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaHyponatremiaEUCTR2006-002567-62-CZCardiokine Biopharma, LLC650
进行中（未招募）
不适用
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluationEstudio BALANCE: Tratamiento de la Hyponatremia mediante lixivaptan en la evaluación del paciente con insuficiencia cardiaca con Clase III/IV de la NYHAHyponatremiaHiponatremiaMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaEUCTR2006-002567-62-ESCardiokine Biopharma, LLC650
进行中（未招募）
不适用
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluatioMedDRA version: 9.1Level: LLTClassification code 10021038Term: HyponatremiaHyponatremiaEUCTR2006-002567-62-DECardiokine Biopharma, LLC650