Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259116
Status:
COMPLETED
Last Update Posted:
2009-04-15
First Post:
2005-11-28
Brief Title:
A Pilot Study of Recombinant Human Relaxin rhRlx in Compensated Congestive Heart Failure
Sponsor:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Organization:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Study Overview
Official Title:
A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin rhRlx in Compensated Congestive Heart Failure
Status:
COMPLETED
Status Verified Date:
2009-04
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:
None
Brief Summary:
This trial is a single center open-label dose-finding study of recombinant human relaxin rhRlx given intravenously IV to patients with stable compensated CHF
Detailed Description:
Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria Dose escalation will be guided by hemodynamic response safety and tolerability The effects of rhRlx on hemodynamics will be assessed
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