NCT00728091终止3 期
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- serum sodium change from baseline
研究概览
简要总结
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.
Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.
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
- Quadruple (Participant, Care Provider, 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
- •Participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia
排除标准
- •Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor)
- •Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension)
- •Participants with adrenocortical insufficiency
- •Participants with hypothyroidism
- •Participants with known causes of transient SIADH
- •Participants with psychogenic polydipsia or beer potomania
- •Concomitant use of thiazide diuretics during the study
- •Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening
- •Participants with impaired hepatic function or liver cirrhosis (Child-Pugh A-C)
- •Pregnant or breast-feeding women
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Satavaptan Dose 1
Experimental
Fixed Low dose up to day 4, followed by optional titration up to day 30
干预措施: Satavaptan (Drug)
Satavaptan Dose 2
Experimental
Fixed High dose up to day 4, followed by optional titration up to day 30
干预措施: Satavaptan (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
serum sodium change from baseline
时间窗: At Day 5 pre-dose
次要结局
- responder rate(At Day 5 pre-dose)
- presence and intensity of clinical symptoms related to hyponatremia(At each scheduled visit)
- change from baseline in cognitive function(At Day 5 and 30)
研究者
研究点 (1)
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