Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00359437

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 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	Intervention	Phase
Ascites Liver Cirrhosis	Drug: satavaptan (SR121463B) Drug: placebo	Phase III

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	450
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
1: Experimental	Drug: satavaptan (SR121463B) oral administration once daily
2: Placebo Comparator	Drug: placebo oral administration once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cirrhosis of the liver.
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 > 4 litres of fluid.
- at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

Patients with an existing functional TIPS (transjugular intrahepatic portosystemic shunt) 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359437

Show 24 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC4493, EUDRACT: 2006-000132-27, LTS10036
Study First Received:	August 1, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00359437
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis

Ascites
Liver Cirrhosis
Recurrence

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009