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Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
NCT00501722 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00501722
The ClinicalTrials.gov registry entry for NCT00501722 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00501722 reports 13 study locations spanning 4 distinct geographic areas — top geographies include Other, New Jersey, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00501722?
The interventions under investigation include: satavaptan (SR121463B) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00501722?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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