Clinical Trial: Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Se

Brief Summary: 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.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: Clinical status at day 120.

Original Primary Outcome:

Current Secondary Outcome: NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: March 29, 2002
Date Started: August 2001
Date Completion:
Last Updated: June 16, 2008
Last Verified: June 2008