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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501566
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
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.
Information provided by:
Sanofi
  Purpose

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 Intervention Phase
Ascites Liver Cirrhosis Drug: satavaptan (SR121463B) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • Abdominal girth and discomfort [ Time Frame: 14 days ]
  • Paracentesis [ Time Frame: 14 days ]
  • Quality of life [ Time Frame: 14 days ]

Enrollment: 148
Study Start Date: April 2004
Study Completion Date: January 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00501566


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00501566     History of Changes
Other Study ID Numbers: DFI5563
SR121463
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
Last Verified: July 2007

Keywords provided by Sanofi:
cirrhotic ascites

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