Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Primary Purpose
Syndrome of Inappropriate ADH (SIADH) Secretion, Hyponatremia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
satavaptan (SR121463B)
Sponsored by
About this trial
This is an interventional treatment trial for Syndrome of Inappropriate ADH (SIADH) Secretion focused on measuring Low Blood Sodium (Hyponatremia), SIADH, Inappropriate ADH Syndrome
Eligibility Criteria
SIADH of any origin
Sites / Locations
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
- Sanofi-aventis Administrative Office
Outcomes
Primary Outcome Measures
serum sodium concentration
Secondary Outcome Measures
safety assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00032734
Brief Title
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndrome of Inappropriate ADH (SIADH) Secretion, Hyponatremia
Keywords
Low Blood Sodium (Hyponatremia), SIADH, Inappropriate ADH Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
satavaptan (SR121463B)
Primary Outcome Measure Information:
Title
serum sodium concentration
Secondary Outcome Measure Information:
Title
safety assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
SIADH of any origin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-aventis Administrative Office
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Links:
URL
http://www.centerwatch.com
Description
Related Info
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
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