Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
Completed · Phase 2
Conditions studied: Chronic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00032747
- Run by
- Sanofi
- People needed
- 338
- Starts
- 2001-08-01
- Expected to finish
- 2003-02-01
- Last updated by the study team
- 2008-06-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Emory University — Atlanta, Georgia, United States
- University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Brian LGH Heart Institute — Lincoln, Nebraska, United States
- The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
- MUSC/Division Cardiology — Charleston, South Carolina, United States
- Sanofi-aventis Administrative Office — Laval, Canada
- Sanofi-aventis Administrative Office — Guildford Surrey, United Kingdom
Full record on ClinicalTrials.gov
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