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Sponsored by: |
VIA Pharmaceuticals |
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Information provided by: | VIA Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00352417 |
This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation in patients with carotid stenosis scheduled for elective carotid endarterectomy
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis |
Drug: VIA-2291 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | VIA-2291-02, A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effects of VIA-2291 on Atherosclerotic Plaque and Vascular Inflammation in Patients With Carotid Stenosis Undergoing Elective Carotid Endarterectomy |
Enrollment: | 50 |
Study Start Date: | July 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
VIA-2291
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Drug: VIA-2291
100 mg, oral dosing, 1 time daily for 12 weeks
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2: Placebo Comparator
Matching Placebo
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Drug: Placebo
oral dosing, 1 time daily for 12 weeks
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This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients scheduled for elective carotid endarterectomy
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
VIA Pharmaceuticals, Inc | |
San Francisco, California, United States, 94111 | |
United States, New Jersey | |
VIA Pharmaceuticals, Inc. | |
Princeton, New Jersey, United States, 08540 |
Study Director: | Rebecca Taub, MD | VIA Pharmaceuticals |
Responsible Party: | VIA Pharmaceuticals, Inc. ( Rebecca Taub, MD; Sr. Vice President, Research and Development ) |
Study ID Numbers: | VIA-2291-02, EudraCT No. 2006-001635-21 |
Study First Received: | July 12, 2006 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00352417 |
Health Authority: | Italy: Ethics Committee |
Arterial Occlusive Diseases Atherosclerosis Carotid Stenosis Vascular Diseases |
Constriction, Pathologic Arteriosclerosis Inflammation |
Pathologic Processes Cardiovascular Diseases |