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Completed

NCT Number: NCT00501722

Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites

The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).

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Key information

Conditions

Ascites Digestive System Diseases Fibrosis Hyponatremia Liver Cirrhosis Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

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
  • Patients with hyponatremia, defined as a serum sodium concentration 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, change in serum sodium

    Time frame: within 14 days

Secondary outcomes

  1. abdominal girth and discomfort

    Time frame: 14 days

  2. paracentesis

    Time frame: 14 days

  3. trail-making test and 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 Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

Acronym: Hypo~CAT

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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