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

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: NCT00359437
Recruitment Status : Terminated
First Posted : August 2, 2006
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Ascites Liver Cirrhosis Drug: Satavaptan Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 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 With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Study Start Date : July 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Satavaptan Drug: Satavaptan
oral administration once daily
Other Name: SR121463B
Placebo Comparator: Placebo Drug: placebo
oral administration once daily


Outcome Measures
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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 ]

Eligibility Criteria
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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:

  • 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
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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


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
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, 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
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00359437    
Other Study ID Numbers: EFC4493
EUDRACT: 2006-000132-27
LTS10036
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: May 24, 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