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

Phase 2

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT00032747
• Lead Sponsor: Sanofi

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 Description

Not available

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-03-29
• Study First Submitted QC: 2002-03-29
• Study First Posted: 2002-04-01
• Study Completion: 2003-02
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-16
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical status at day 120.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Emory University; 🇺🇸 Atlanta, Georgia, United States

MUSC/Division Cardiology; 🇺🇸 Charleston, South Carolina, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Brian LGH Heart Institute; 🇺🇸 Lincoln, Nebraska, United States

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States

The Lindner Clinical Trial Center; 🇺🇸 Cincinnati, Ohio, United States

Sanofi-aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom