Back to resultsSatavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites (Hypo~CAT)
Primary Purpose
Ascites, Liver Cirrhosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
satavaptan (SR121463B)
Sponsored by
About this trial
This is an interventional treatment trial for Ascites focused on measuring cirrhotic ascites, hyponatraemia
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
change in body weight, change in serum sodium
Secondary Outcome Measures
abdominal girth and discomfort
paracentesis
trail-making test and quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501722
Brief Title
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
Acronym
Hypo~CAT
Official Title
SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Liver Cirrhosis
Keywords
cirrhotic ascites, hyponatraemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
satavaptan (SR121463B)
Primary Outcome Measure Information:
Title
change in body weight, change in serum sodium
Time Frame
within 14 days
Secondary Outcome Measure Information:
Title
abdominal girth and discomfort
Time Frame
14 days
Title
paracentesis
Time Frame
14 days
Title
trail-making test and quality of life
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Cove
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18508290
Citation
Gines 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. doi: 10.1002/hep.22293.
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
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Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
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