Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032747
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2002-03-29
Brief Title:
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure AQUAVIT
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Placebo-Controlled Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure
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:
This is a randomized double-blind placebo-controlled parallel-group forced up-titration study Randomization will be stratified according to the patients baseline serum sodium concentration 137-144 and 137 mmolL The dose of study drug will be increased to the next level on Day 15 and the total duration of the double-blind treatment period is 120 days
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 |
|---|---|---|---|
| SR121463B | None | None | None |