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Completed

NCT Number: NCT00501384

Satavaptan Dose-Ranging Study in the Prevention of Ascites

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

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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
  • Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
  • Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months

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. Time to repeat therapeutic paracentesis

    Time frame: 12 weeks

Secondary outcomes

  1. Increase in ascites judged by body weight and ascites volume

    Time frame: within 12 weeks

  2. frequency of paracentesis

    Time frame: 12 weeks

  3. quality of life

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

Acronym: SPA

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jul 16, 2007
Registry last updated
Jan 12, 2009

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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