CClinicalTrials.gg
CompletedNCT00570752Updated Dec 7, 2015

Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

A Phase 2 interventional study of Placebo and BMS-582949 in Vascular Diseases, sponsored by Bristol-Myers Squibb. Completed at 17 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-12-07.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque

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Conditions studied

  • Vascular Diseases

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03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 72 is close to the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of documented atherosclerosis
  • 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

Exclusion Criteria:

  • Statin intolerance
  • 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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Placebo + background low to moderate dose statin

    Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks

    Other: Placebo · Drug: Statin

  • Experimental
    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

    Drug: BMS-582949 · Drug: Statin

  • Active comparator
    Atorvastatin

    Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks

    Drug: Atorvastatin

Interventions

  • OtherPlacebo
  • DrugBMS-582949
  • DrugAtorvastatin
  • DrugStatin
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What researchers measure

Primary outcomes

  1. FDG-PET signal of the carotid and/or ascending aorta

    Time frame: at 4 and 12 weeks

Secondary outcomes

  1. Inflammatory and thrombotic biomarkers

    Time frame: will be measured throughout the 12 weeks of treatment

07

Study locations

17 sites
  • Southeast Clinical Research, Llc
    Chiefland, Florida 32626, United States
  • Jacksonville Center For Clinical Research - Univ Campus
    Jacksonville, Florida 32216, United States
  • Florida Cardiovascular Institute
    Tampa, Florida 33609, United States
  • Phillip D. Toth, Md
    Indianapolis, Indiana 46260, United States
  • L-Marc Research Center
    Louisville, Kentucky 40213, United States
  • Commonwealth Biomedical Research, Llc
    Madisonville, Kentucky 42431, United States
  • Mgh Cardiac Mr Pet Ct Program
    Boston, Massachusetts 02114, United States
  • Troy Internal Medince Pc/Research
    Troy, Michigan 48098, United States
  • Radiant Research, Inc.
    Edina, Minnesota 55435, United States
  • Mount Sinai School Of Medicine Imaging Science Laboratories
    New York, New York 10029, United States
  • The Lipid Center
    Statesville, North Carolina 28677, United States
  • Metabolic And Atherosclerosis Research Center
    Cincinnati, Ohio 45212, United States
  • Sterling Research Group
    Cincinnati, Ohio 45219, United States
  • Hospital Of The University Of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Radiant Research, Inc.
    Dallas, Texas 75231, United States
  • Baylor College Of Medicine
    Houston, Texas 77030, United States
  • Mcallen Heart Clinic
    Mc Allen, Texas 78503, United States
08

References and documents

Publications

  • 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. PubMed 25913664 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00570752
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Dec 11, 2007
Start date
Dec 2008
Primary completion
Nov 2010
Completion
Dec 2010
Last update
Dec 7, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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