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

NCT00264927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2008-12-10

No results posted yet for this study

Summary

To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH.

The double blind period is followed by an open label extension study with flexible doses of satavaptan.

Conditions

Interventions

DRUG

SR121463B

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Germany
  • Hong Kong
  • Hungary
  • Netherlands
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00264927 on ClinicalTrials.gov