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NCT00501722 · ClinicalTrials.gov registry record · Phase 2
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
A Phase 2 study of Liver Cirrhosis and Ascites, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 13
- Study locations
NCT00501722: Completed Phase 2 study of Liver Cirrhosis and Ascites, sponsored by Sanofi.
NCT00501722 is a Phase 2 study of Liver Cirrhosis and Ascites that has completed, run by Sanofi. The registered enrollment target is 110 participants, below the 998-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (89% lower). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501722, a Phase 2 study of Liver Cirrhosis and Ascites, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 13
- Study locations
Study 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 Studied
Interventions
- DRUG satavaptan (SR121463B)
Study Locations (13)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- Sanofi-Aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - Zagreb
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Bucharest
- Sanofi-Aventis Administrative Office - Barcelona
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
New South Wales
- Sanofi-Aventis Administrative Office - Cove
Quebec
- Sanofi-Aventis Administrative Office - Laval
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
What the finished NCT00501722 record still lists
NCT00501722 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 998-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Liver Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which satavaptan (SR121463B) is the first listed.
NCT00501722 lists 13 locations in 4 states (Other, New Jersey, New South Wales).
Frequently Asked Questions
What is clinical trial NCT00501722 about?
NCT00501722 is a clinical study titled "Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites". 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 ...
What is the current status of trial NCT00501722?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2004-04. Estimated completion is 2005-03.
What conditions does trial NCT00501722 study?
This clinical trial studies the following conditions: Liver Cirrhosis, Ascites.
What interventions are being tested in trial NCT00501722?
The interventions under investigation include: satavaptan (SR121463B) (DRUG).
Who is sponsoring clinical trial NCT00501722?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00501722 being conducted?
This trial has 13 study locations across New Jersey, New South Wales, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00501722's enrollment target sits among peer trials
110 9th of 15 higher than 7 of 15 other Liver Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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