Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501384
Status:
COMPLETED
Last Update Posted:
2009-01-12
First Post:
2007-07-13
Brief Title:
Satavaptan Dose-Ranging Study in the Prevention of Ascites
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Study for the Prevention of Ascites SPA Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
Status:
COMPLETED
Status Verified Date:
2009-01
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:
SPA
Brief Summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites when used concomitantly with a standard dose regimen of spironolactone
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites over a 12-week treatment period
This SPA study is followed by a single-blind placebo-controlled 40 weeks long-term safety extension ExSPA The first extension is followed by another long-term study PASCCAL-1
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites over a 12-week treatment period
This SPA study is followed by a single-blind placebo-controlled 40 weeks long-term safety extension ExSPA The first extension is followed by another long-term study PASCCAL-1
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LTS10209 | None | None | None |
| LTS5635 | None | None | None |