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Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
BMS-582949
Atorvastatin
Statin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Southeast Clinical Research, Llc
  • Jacksonville Center For Clinical Research - Univ Campus
  • Florida Cardiovascular Institute
  • Phillip D. Toth, Md
  • L-Marc Research Center
  • Commonwealth Biomedical Research, Llc
  • Mgh Cardiac Mr Pet Ct Program
  • Troy Internal Medince Pc/Research
  • Radiant Research, Inc.
  • Mount Sinai School Of Medicine Imaging Science Laboratories
  • The Lipid Center
  • Metabolic And Atherosclerosis Research Center
  • Sterling Research Group
  • Hospital Of The University Of Pennsylvania
  • Radiant Research, Inc.
  • Baylor College Of Medicine
  • Mcallen Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Placebo + background low to moderate dose statin

BMS-582949 + Background low to moderate dose statin

Atorvastatin

Arm Description

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

BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory and thrombotic biomarkers

Full Information

First Posted
December 10, 2007
Last Updated
November 6, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00570752
Brief Title
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
Official Title
A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + background low to moderate dose statin
Arm Type
Active Comparator
Arm Description
Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
Arm Title
BMS-582949 + Background low to moderate dose statin
Arm Type
Experimental
Arm Description
BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
BMS-582949
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Statin
Primary Outcome Measure Information:
Title
FDG-PET signal of the carotid and/or ascending aorta
Time Frame
at 4 and 12 weeks
Secondary Outcome Measure Information:
Title
Inflammatory and thrombotic biomarkers
Time Frame
will be measured throughout the 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Southeast Clinical Research, Llc
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Jacksonville Center For Clinical Research - Univ Campus
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Cardiovascular Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Phillip D. Toth, Md
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
L-Marc Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Commonwealth Biomedical Research, Llc
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Mgh Cardiac Mr Pet Ct Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Troy Internal Medince Pc/Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mount Sinai School Of Medicine Imaging Science Laboratories
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Lipid Center
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Metabolic And Atherosclerosis Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hospital Of The University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mcallen Heart Clinic
City
Mc Allen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25913664
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

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