Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

Completed

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Key information

Conditions

Syndrome of Inappropriate ADH (SIADH) Secretion Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyponatremia Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases 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, Diegem, Belgium

About this study

This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Who can participate

Healthy volunteers accepted: No

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

SIADH of any origin

Treatment and study plan

satavaptan (SR121463B)

Drug

Primary outcomes

serum sodium concentration

Secondary outcomes

safety assessment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.

Important dates

Study start: 2001
Study completion: 2003
First posted: Apr 1, 2002
Registry last updated: Jun 17, 2008

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.

Published trials that share one or more normalized conditions with this study.

Completed