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Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-1)

This study has been terminated.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: August 1, 2006
Last updated: April 25, 2016
Last verified: April 2016

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Condition Intervention Phase
Liver Cirrhosis
Drug: Satavaptan
Drug: placebo
Phase 3

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: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number and time of recurrences of therapeutic paracenteses [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomisation to first recurrence of ascites [ Time Frame: study period ] [ Designated as safety issue: No ]
  • Increase in ascites [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Satavaptan Drug: Satavaptan
oral administration once daily
Other Name: SR121463B
Placebo Comparator: Placebo Drug: placebo
oral administration once daily


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

Inclusion Criteria:

  • Participants with cirrhosis of the liver.
  • Participants with recurrent ascites having undergone both of the following:

    • therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of > 4 litres of fluid.
    • at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

  • Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
  • Known hepatocellular carcinoma.
  • Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma.
  • Participants previously exposed to satavaptan in the past 12 months.
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Please refer to this study by its identifier: NCT00359437

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Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00359437     History of Changes
Other Study ID Numbers: EFC4493  EUDRACT: 2006-000132-27  LTS10036 
Study First Received: August 1, 2006
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Disease Attributes
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs processed this record on October 20, 2016