Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00525707
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2007-08-31
Brief Title:
Tezosentan in Acute Heart Failure
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Multicenter Double-blind Randomized Placebo-controlled Parallel Group Study to Assess the Efficacy Safety and Tolerability of Tezosentan in Patients With Acute Heart Failure
Status:
COMPLETED
Status Verified Date:
2018-07
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:
VERITAS 1
Brief Summary:
The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mgh for the first 30 minutes and 1 mgh thereafter or matching placebo in a 11 manner The duration of the treatment is 24 hours up to 72 hours The duration of the follow-up period is 30 days after treatment initiation for death re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status
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