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OpenTrials
Completed

NCT Number: NCT00501566

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites

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.

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Key information

Conditions

Ascites Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

satavaptan (SR121463B)

Drug

Primary outcomes

  1. Change in body weight

    Time frame: within 14 days

Secondary outcomes

  1. Abdominal girth and discomfort

    Time frame: 14 days

  2. Paracentesis

    Time frame: 14 days

  3. Quality of life

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

Acronym: Normo~CAT

Important dates

Study start
2004
Study completion
2005
First posted
Jul 16, 2007
Registry last updated
Jul 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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