A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure

Sanofi16 个研究点分布在 3 个国家目标入组 338 人开始时间: 2001年8月最近更新: 2008年6月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Sanofi
入组人数: 338
试验地点: 16
主要终点: Clinical status at day 120.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Clinical status at day 120.

次要结局

NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (16)

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