Trials / Completed
CompletedNCT00501722
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites. This Hypo\~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo\~CAT). The first extension is followed by another long-term study (PASCCAL-1).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | satavaptan (SR121463B) |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2005-03-01
- Completion
- 2005-03-01
- First posted
- 2007-07-16
- Last updated
- 2009-01-12
Locations
13 sites across 13 countries: United States, Argentina, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Hungary, Italy, Romania, Spain
Source: ClinicalTrials.gov record NCT00501722. Inclusion in this directory is not an endorsement.