NCT00032734

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2001

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

First QC Date

March 29, 2002

Last Update Submit

June 16, 2008

Conditions

Syndrome of Inappropriate ADH (SIADH) SecretionHyponatremia

Keywords

Low Blood Sodium (Hyponatremia)SIADHInappropriate ADH Syndrome

Outcome Measures

Primary Outcomes (1)

  • serum sodium concentration

Secondary Outcomes (1)

  • safety assessment

Interventions

satavaptan (SR121463B)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
SIADH of any origin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Sanofi-aventis Administrative Office

Diegem, Belgium

Location

Sanofi-aventis Administrative Office

Paris, France

Location

Sanofi-aventis Administrative Office

Berlin, Germany

Location

Sanofi-aventis Administrative Office

Budapest, Hungary

Location

Related Links

MeSH Terms

Conditions

Inappropriate ADH SyndromeHyponatremia

Interventions

satavaptan

Condition Hierarchy (Ancestors)

Pituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2002

First Posted

April 1, 2002

Study Start

June 1, 2001

Study Completion

July 1, 2003

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

FR(1)HU(1)DE(1)BE(1)