Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032734
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2002-03-29
Brief Title:
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LTS10208 | None | None | None |
| SR121463 | None | None | None |
| LTS5066 | None | None | None |