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Satavaptan Dose-Ranging Study in the Prevention of Ascites (SPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501384
First Posted: July 16, 2007
Last Update Posted: January 12, 2009
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:
Sanofi
July 13, 2007
July 16, 2007
January 12, 2009
April 2004
May 2005   (Final data collection date for primary outcome measure)
Time to repeat therapeutic paracentesis [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00501384 on ClinicalTrials.gov Archive Site
  • Increase in ascites judged by body weight and ascites volume [ Time Frame: within 12 weeks ]
  • frequency of paracentesis [ Time Frame: 12 weeks ]
  • quality of life [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Satavaptan Dose-Ranging Study in the Prevention of Ascites
Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Ascites
  • Liver Cirrhosis
Drug: satavaptan (SR121463B)
Not Provided
Wong F, Gines P, Watson H, Horsmans Y, Angeli P, Gow P, Minini P, Bernardi M. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010 Aug;53(2):283-90. doi: 10.1016/j.jhep.2010.02.036. Epub 2010 May 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
May 2005
May 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
  • Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
  • Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Italy,   Spain,   Taiwan
 
 
NCT00501384
DFI4522
LTS5635
LTS10209
Yes
Not Provided
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP