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Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites (Normo~CAT)

Primary Purpose

Ascites, Liver Cirrhosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
satavaptan (SR121463B)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites focused on measuring cirrhotic ascites

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Outcomes

Primary Outcome Measures

Change in body weight

Secondary Outcome Measures

Abdominal girth and discomfort
Paracentesis
Quality of life

Full Information

First Posted
July 13, 2007
Last Updated
July 13, 2007
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00501566
Brief Title
Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
Acronym
Normo~CAT
Official Title
SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
satavaptan (SR121463B)
Primary Outcome Measure Information:
Title
Change in body weight
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
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 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.
Facility Information:
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
Milan
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

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

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