Trials / Completed
CompletedNCT00358878
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 463 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Satavaptan | oral administration once daily |
| DRUG | placebo | oral administration once daily |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2006-08-01
- Last updated
- 2016-05-26
Locations
21 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Denmark, France, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Russia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00358878. Inclusion in this directory is not an endorsement.