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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00501722
First received: July 13, 2007
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501722

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

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00501722     History of Changes
Other Study ID Numbers: DFI4521, LTS5634, LTS10209
Study First Received: July 13, 2007
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
Romania: National Medicines Agency
Croatia: Ministry of Health and Social Care

Keywords provided by Sanofi:
cirrhotic ascites
hyponatraemia

Additional relevant MeSH terms:
Ascites
Hyponatremia
Liver Cirrhosis
Fibrosis
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014