Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424866
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2007-01-18
Brief Title:
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
Sponsor:
CardioVascular BioTherapeutics Inc
Organization:
CardioVascular BioTherapeutics Inc
Study Overview
Official Title:
A Phase 1 Open Label Dose Response Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 FGF-1 in Peripheral Arterial Disease Patients With Intermittent Claudication
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_RECRUITING
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:
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication
Detailed Description:
FGF-1 administered by intramuscular injection for the treatment of peripheral arterial disease with intermittent claudication Eligible patients are allocated to one of three treatment arms Patients within each dosing group will be randomized between study drug and vehicle control Safety pharmacokinetics and cardiovascular improvement will be evaluated at day 1 and weeks 1 4 and 12 post dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None