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Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy

NCT ID: NCT00352417

Last Updated: 2012-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-07-31

Brief Summary

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This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VIA-2291

Group Type EXPERIMENTAL

VIA-2291

Intervention Type DRUG

100 mg, oral dosing, 1 time daily for 12 weeks

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral dosing, 1 time daily for 12 weeks

Interventions

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VIA-2291

100 mg, oral dosing, 1 time daily for 12 weeks

Intervention Type DRUG

Placebo

oral dosing, 1 time daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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atreleuton

Eligibility Criteria

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Inclusion Criteria

* Female patients must be of non-childbearing potential
* Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery
* One or more of the following clinical features: Prior history \>4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time
* Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting blood glucose levels \>6.9 mmol/L
* Baseline hsCRP \>2 mg/L
* Echolucent plaque

Exclusion Criteria

* Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy
* Renal insufficiency defined as creatinine \>1.5 x upper limit of normal (ULN)
* Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) \>1 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
* Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c \>11% at screening
* Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
* Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery (within 4 weeks of enrollment)
* Current atrial fibrillation
* Planned cardiac intervention
* Acetaminophen use in any form in the 7 days before enrollment
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tallikut Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Taub, MD

Role: STUDY_DIRECTOR

VIA Pharmaceuticals

Locations

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Azienda Ospedali Riuniti Ancona

Ancona, , Italy

Site Status

Presidio Ospedaliero SS Filippo e Nicola

Avezzano, , Italy

Site Status

Centro Studi Sull'Invecchiamento

Chieti Scalo, , Italy

Site Status

Countries

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United States Italy

Other Identifiers

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2006-001635-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIA-2291-02

Identifier Type: -

Identifier Source: org_study_id