Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113009
Status:
COMPLETED
Last Update Posted:
2007-11-22
First Post:
2005-06-02
Brief Title:
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Sponsor:
Valentis
Organization:
Valentis
Study Overview
Official Title:
A Phase II Multi-Center Randomized Double-Blind Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2006-03
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 phase II multicenter randomized double-blind placebo-controlled trial in which subjects with intermittent claudication IC will be randomized to receive a single treatment of VLTS-934 84 mL or a total of 420 mg poloxamer 188 or placebo 84 mL saline administered as 21 intramuscular IM injections of 2 mL each bilaterally into the lower extremities during one procedure to evaluate the safety tolerability and potential activity of VLTS-934 as compared with a saline placebo
Detailed Description:
This is a Phase II multicenter randomized double-blind placebo-controlled trial in which subjects with IC will be randomized to receive a single treatment of VLTS-934 84 mL or a total of 420 mg poloxamer 188 or placebo 84 mL saline administered as 21 intramuscular IM injections of 2 mL each bilaterally into the lower extremities during one procedure to evaluate the safety tolerability and potential activity of VLTS-934 as compared with a saline placebo
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