Study Effect of VIA-2291 on Vascular Inflammation - Full Text View

Sponsors and Collaborators:	VIA Pharmaceuticals Montreal Heart Institute
Information provided by:	VIA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00358826

Purpose

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Condition	Intervention	Phase
Coronary Artery Disease	Drug: VIA-2291 Drug: Placebo	Phase II

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Study Protocol No. VIA-2291-01, A Phase 2 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging Study of the Effect of VIA-2291 on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event

Further study details as provided by VIA Pharmaceuticals:

Primary Outcome Measures:

Changes in biomarkers of vascular inflammation [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in biomarkers of vascular inflammation [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental VIA-2291 25 mg	Drug: VIA-2291 25 mg oral dosing, 1 time daily for 12 or 24 weeks
2: Experimental VIA-2291 50 mg	Drug: VIA-2291 50 mg oral dosing, 1 time daily for 12 or 24 weeks
3: Experimental VIA-2291 100 mg	Drug: VIA-2291 100 mg oral dosing, 1 time daily for 12 or 24 weeks
4: Placebo Comparator Placebo	Drug: Placebo oral dosing, 1 time daily for 12 or 24 weeks

Detailed Description:

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female patients are to be of non-childbearing potential
Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
Patient has documented coronary artery disease

Exclusion Criteria:

Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)
Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other liver function test
Uncontrolled diabetes mellitus within 1 month prior to study screening
Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
Previous coronary artery bypass graft (CABG) surgery
Planned additional cardiac intervention
Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
Acetaminophen use in any form in the 7 days before enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358826

Locations

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

Sponsors and Collaborators

VIA Pharmaceuticals

Montreal Heart Institute

Investigators

Study Director:

Rebecca Taub, MD

VIA Pharmaceuticals

More Information

Responsible Party:	VIA Pharmaceuticals, Inc ( Rebecca Taub, MD; Sr. Vice President, Research and Development )
Study ID Numbers:	VIA-2291-01
Study First Received:	July 28, 2006
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00358826
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009