Ignite Creation Date:
2025-12-18 @ 4:26 AM
Ignite Modification Date:
2025-12-18 @ 4:26 AM
Study NCT ID:
NCT00728091
Status:
None
Last Update Posted:
2016-05-26 00:00:00
First Post:
2008-07-31 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia
Sponsor:
None
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Status:
None
Status Verified Date:
2016-04
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:
AQUARIST1
Brief Summary:
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.
Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.
Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.
Detailed Description:
None
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?: