Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic 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

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

Current Primary Outcome Measures ^ICMJE

change in body weight, change in serum sodium [ Time Frame: within 14 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00501722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

abdominal girth and discomfort [ Time Frame: 14 days ]
paracentesis [ Time Frame: 14 days ]
trail-making test and 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 Hyponatraemic Patients With Cirrhotic Ascites

Official Title ^ICMJE

SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: 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 and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). 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 *

Ginès P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D; HypoCAT Study Investigators. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008 Jul;48(1):204-13.

* 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

110

Completion Date

March 2005

Primary Completion Date

March 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
Moderate or tense ascites
Patients with hyponatremia, defined as a serum sodium concentration 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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain

Administrative Information

NCT ID ^ICMJE

NCT00501722

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

DFI4521, LTS5634, 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