Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

NCT ID: NCT00501566

Last Updated: 2007-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ascites Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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satavaptan (SR121463B)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Locations

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Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Cove, New South Wales, Australia

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

Laval, Quebec, Canada

Site Status

Sanofi-Aventis Administrative Office

Zagreb, , Croatia

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Countries

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Argentina Australia Belgium Canada Croatia Czechia France Germany Hungary Italy Romania Spain

Related Links

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Other Identifiers

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SR121463

Identifier Type: -

Identifier Source: secondary_id

DFI5563

Identifier Type: -

Identifier Source: org_study_id