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Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites (Hypo~CAT)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 13, 2007
Last updated: January 9, 2009
Last verified: January 2009

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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: 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, change in serum sodium [ Time Frame: within 14 days ]

Secondary Outcome Measures:
  • abdominal girth and discomfort [ Time Frame: 14 days ]
  • paracentesis [ Time Frame: 14 days ]
  • trail-making test and quality of life [ Time Frame: 14 days ]

Enrollment: 110
Study Start Date: April 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

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
  • Patients with hyponatremia, defined as a serum sodium concentration 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00501722

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
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
Milano, Italy
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00501722     History of Changes
Other Study ID Numbers: DFI4521
Study First Received: July 13, 2007
Last Updated: January 9, 2009

Keywords provided by Sanofi:
cirrhotic ascites

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs processed this record on September 21, 2017