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NCT00359437 · ClinicalTrials.gov registry record · Phase 3
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
NCT00359437 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 501 participants.
The verdict
NCT00359437, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
Study Summary
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
Interventions
- DRUG placebo
- DRUG Satavaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00359437
The ClinicalTrials.gov registry entry for NCT00359437 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00359437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00359437 about?
NCT00359437 is a clinical study titled "Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver". Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. ...
What is the current status of trial NCT00359437?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2006-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00359437?
The interventions under investigation include: placebo (DRUG), Satavaptan (DRUG).
Who is sponsoring clinical trial NCT00359437?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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