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Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-2)

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.
 
ClinicalTrials.gov Identifier: NCT00366795
Recruitment Status : Terminated (Study was terminated due to safety reason.)
First Posted : August 21, 2006
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients 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 or disease Intervention/treatment Phase
Ascites Liver Cirrhosis Drug: Satavaptan Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
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 in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Study Start Date : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: Satavaptan Drug: Satavaptan
oral administration once daily
Other Name: SR121463B

Placebo Comparator: Placebo Drug: placebo
oral administration once daily




Primary Outcome Measures :
  1. Number and time of recurrences of therapeutic paracenteses [ Time Frame: up to 12 weeks ]

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


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with cirrhosis of the liver.
  • Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
  • Patients 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 = or > 4 litres of fluid.
    • at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

  • Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
  • Known hepatocellular carcinoma.
  • Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
  • Patients previously exposed to satavaptan in the past 12 months.

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): NCT00366795


Locations
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United States, Pennsylvania
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
Argentina
Sanofi-Aventis Administrative Office
San Isidro, Argentina
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Bosnia and Herzegovina
Sanofi-Aventis Administrative Office
Sarajevo, Bosnia and Herzegovina
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00366795    
Other Study ID Numbers: EFC6682
EudraCT : 2006-000132-27
LTS10036
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
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