Satavaptan Dose-Ranging Study in the Prevention of Ascites - Tabular View

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

January 9, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to repeat therapeutic paracentesis [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00501384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Satavaptan Dose-Ranging Study in the Prevention of Ascites

Official Title ^ICMJE

Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

Brief Summary

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).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), 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

151

Completion Date

May 2005

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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, Italy, Spain, Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00501384

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

DFI4522, LTS5635, LTS10209

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

January 2009

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