Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111826
Status:
TERMINATED
Last Update Posted:
2010-03-31
First Post:
2005-05-25
Brief Title:
SIMPADICO - Study of Immune Modulation Therapy in Peripheral Arterial Disease and Intermittent Claudication Outcomes
Sponsor:
Vasogen
Organization:
Vasogen
Study Overview
Official Title:
Multi-Center Randomized Double-Blind Placebo-Controlled Study of Efficacy and Safety of the Celacade System in Improving Walking Distance in Patients With Intermittent Claudication Secondary to Peripheral Arterial Disease
Status:
TERMINATED
Status Verified Date:
2007-11
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:
The purpose of this study is to assess the effects of the Celacade system in patients with intermittent claudication
Detailed Description:
SIMPADICO was a multicenter randomized double-blind placebo-controlled trial that enrolled 553 patients with claudication at 50 sites in Canada and the United States The mean SD patient age was 6710 years 72 were males The duration of claudication was 6061 years at entry 91 had a history of smoking and 34 were current smokers 365 had diabetes Resting ABI was 059014 baseline ICD was 132104 and ACD 307209 meters Results showed that there was no increase in ACD or ICD at 26 weeks with immune modulation therapy IMT using the Celacade system Vasogen Inc compared to placebo and no measurable improvement in quality of life with IMT compared to placebo However there was a significant decrease in CRP high sensitivity assay in in the IMT group compared to the placebo group Conclusion Immune modulation therapy did not improve walking distance in patients with symptomatic peripheral arterial disease but the decrease in CRP suggests a biologic effect of IMT and will warrant further study
Reference A Multicenter Randomized Double-Blind Placebo-Controlled Study of Immune Modulation Therapy in Patients with Symptomatic Peripheral Arterial Disease The SIMPADICO Trial Author Jeffrey W Olin Mount Sinai School of Medicine New York NY Presented at Smaller Trial Late-Breaking Clinical trials I Sunday March 12 2006 American College of Cardiology 55th Annual Scientific Sessions March 11-14 2006 Atlanta GA
Reference A Multicenter Randomized Double-Blind Placebo-Controlled Study of Immune Modulation Therapy in Patients with Symptomatic Peripheral Arterial Disease The SIMPADICO Trial Author Jeffrey W Olin Mount Sinai School of Medicine New York NY Presented at Smaller Trial Late-Breaking Clinical trials I Sunday March 12 2006 American College of Cardiology 55th Annual Scientific Sessions March 11-14 2006 Atlanta GA
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