Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
NCT ID: NCT00570752
Last Updated: 2015-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2008-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo + background low to moderate dose statin
Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
Placebo
Statin
BMS-582949 + Background low to moderate dose statin
BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
BMS-582949
Statin
Atorvastatin
Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks
Atorvastatin
Interventions
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Placebo
BMS-582949
Atorvastatin
Statin
Eligibility Criteria
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Inclusion Criteria
* LDL between 70 and 130 mg/dL
* Patients receiving stable low- to moderate-dose statin
* BMI 18-37 kg/m²
* Must be able to swallow tablets
* Must be able to medically tolerate the procedures, contrast medium, and medications involved
Exclusion Criteria
* Renal impairment (serum creatinine \> 1.5 mg/dL)
* History of chronic viral hepatitis or other liver dysfunction
* Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Southeast Clinical Research, Llc
Chiefland, Florida, United States
Jacksonville Center For Clinical Research - Univ Campus
Jacksonville, Florida, United States
Florida Cardiovascular Institute
Tampa, Florida, United States
Phillip D. Toth, Md
Indianapolis, Indiana, United States
L-Marc Research Center
Louisville, Kentucky, United States
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States
Mgh Cardiac Mr Pet Ct Program
Boston, Massachusetts, United States
Troy Internal Medince Pc/Research
Troy, Michigan, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Mount Sinai School Of Medicine Imaging Science Laboratories
New York, New York, United States
The Lipid Center
Statesville, North Carolina, United States
Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio, United States
Sterling Research Group
Cincinnati, Ohio, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Radiant Research, Inc.
Dallas, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Mcallen Heart Clinic
McAllen, Texas, United States
Countries
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References
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Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28.
Related Links
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Investigator Inquiry form
Other Identifiers
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IM119-014
Identifier Type: -
Identifier Source: org_study_id