Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites (Normo~CAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501566
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : July 16, 2007
Information provided by:

Brief Summary:

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

Condition or disease Intervention/treatment Phase
Ascites Liver Cirrhosis Drug: satavaptan (SR121463B) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
Study Start Date : April 2004
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change in body weight [ Time Frame: within 14 days ]

Secondary Outcome Measures :
  1. Abdominal girth and discomfort [ Time Frame: 14 days ]
  2. Paracentesis [ Time Frame: 14 days ]
  3. Quality of life [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
  • Moderate or tense ascites
  • Serum sodium of >130 mmol/l.

The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501566

Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Milan, Italy
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators

Additional Information: Identifier: NCT00501566     History of Changes
Other Study ID Numbers: DFI5563
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: July 16, 2007
Last Verified: July 2007

Keywords provided by Sanofi:
cirrhotic ascites

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs