Trials / Completed
CompletedNCT00501384
Satavaptan Dose-Ranging Study in the Prevention of Ascites
Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (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 reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). 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
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2007-07-16
- Last updated
- 2009-01-12
Locations
11 sites across 11 countries: Argentina, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Italy, Spain, Taiwan
Source: ClinicalTrials.gov record NCT00501384. Inclusion in this directory is not an endorsement.