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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359437
First Posted: August 2, 2006
Last Update Posted: May 24, 2016
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 (Responsible Party):
Sanofi
  Purpose

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
Ascites Liver Cirrhosis Drug: Satavaptan Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Time from randomisation to first recurrence of ascites [ Time Frame: study period ]
  • Increase in ascites [ Time Frame: over 12 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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

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.
  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): NCT00359437


  Show 24 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00359437     History of Changes
Other Study ID Numbers: EFC4493
EUDRACT: 2006-000132-27
LTS10036
First Submitted: August 1, 2006
First Posted: August 2, 2006
Last Update Posted: May 24, 2016
Last Verified: April 2016

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