Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 5:54 AM
Study NCT ID:
NCT00524433
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2007-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tezosentan in the Treatment of Acute Heart Failure
Sponsor:
Idorsia Pharmaceuticals Ltd.
Organization:
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 2
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 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: