Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites - Tabular View

Tracking Information
First Received Date ^ICMJE	July 13, 2007
Last Updated Date	July 13, 2007
Start Date ^ICMJE	April 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: July 13, 2007)	Change in body weight [ Time Frame: within 14 days ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 13, 2007)	Abdominal girth and discomfort [ Time Frame: 14 days ] Paracentesis [ Time Frame: 14 days ] Quality of life [ Time Frame: 14 days ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
Official Title ^ICMJE	SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
Brief Summary	The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Ascites Liver Cirrhosis
Intervention ^ICMJE	Drug: satavaptan (SR121463B)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	148
Completion Date	January 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence Moderate or tense ascites Serum sodium of >130 mmol/l. The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain

Administrative Information
NCT ID ^ICMJE	NCT00501566
Responsible Party
Study ID Numbers ^ICMJE	DFI5563, SR121463
Study Sponsor ^ICMJE	Sanofi-Aventis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Sanofi-Aventis
Verification Date	July 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP