Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274326
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2006-01-09
Brief Title:
DILIPO DILutIonal HyPOnatremia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist SR121463B on Serum Sodium in Patients With Dilutional Hyponatremia
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary
To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis
Secondary
To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients
To assess the safety and tolerability of SR121463B
To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis
Secondary
To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients
To assess the safety and tolerability of SR121463B
Detailed Description:
SR121463B is an orally effective non-peptide potent and highly selective V2 receptor antagonist causing free water elimination in animals and humans
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