Satavaptan Dose-Ranging Study in the Prevention of Ascites (SPA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00501384
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 reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). 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: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to repeat therapeutic paracentesis [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Increase in ascites judged by body weight and ascites volume [ Time Frame: within 12 weeks ]
  • frequency of paracentesis [ Time Frame: 12 weeks ]
  • quality of life [ Time Frame: 12 weeks ]

Enrollment: 151
Study Start Date: April 2004
Study Completion Date: May 2005
Primary Completion Date: May 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
  • Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
  • Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months

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: NCT00501384

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
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
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: NCT00501384     History of Changes
Other Study ID Numbers: DFI4522, LTS5635, LTS10209
Study First Received: July 13, 2007
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Spain: Spanish Agency of Medicines
Italy: Ministry of Health

Keywords provided by Sanofi:
cirrhotic ascites

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014