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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 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.

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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

Liver Cirrhosis Ascites

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

FieldValue
Enrollment Target 110 participants
Start Date 2004-04
Est. Completion 2005-03
Phase Phase 2

Sponsor

Sanofi

713 total trials

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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, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 998-participant average among 15 other Liver Cirrhosis trials with a reported enrollment target (89% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.