Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites - Full Text View

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

This study has been completed.

First Received: July 13, 2007 No Changes Posted

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00501566

Purpose

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.

Condition	Intervention	Phase
Ascites Liver Cirrhosis	Drug: satavaptan (SR121463B)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis

Drug Information available for: SR-121463B

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in body weight [ Time Frame: within 14 days ]

Secondary Outcome Measures:

Abdominal girth and discomfort [ Time Frame: 14 days ]
Paracentesis [ Time Frame: 14 days ]
Quality of life [ Time Frame: 14 days ]

Enrollment:	148
Study Start Date:	April 2004
Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501566

Locations

Argentina
Sanofi-aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
Sanofi-aventis Administrative Office
Cove, New South Wales, Australia
Belgium
Sanofi-aventis Administrative Office
Diegem, Belgium
Canada, Quebec
Sanofi-aventis Administrative Office
Laval, Quebec, Canada
Croatia
Sanofi-aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
France
Sanofi-aventis Administrative Office
Paris, France
Germany
Sanofi-aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-aventis Administrative Office
Milan, Italy
Romania
Sanofi-aventis Administrative Office
Bucuresti, Romania
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	DFI5563, SR121463
Study First Received:	July 13, 2007
Last Updated:	July 13, 2007
ClinicalTrials.gov Identifier:	NCT00501566 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines; Romania: National Medicines Agency; Croatia: Ministry of Health and Social Care; United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

cirrhotic ascites

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Pathologic Processes

Fibrosis
Ascites
Liver Cirrhosis

ClinicalTrials.gov processed this record on February 08, 2010