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Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00570752
Collaborator
(none)
72
Enrollment
17
Locations
3
Arms
24
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. FDG-PET signal of the carotid and/or ascending aorta [at 4 and 12 weeks]

Secondary Outcome Measures

  1. Inflammatory and thrombotic biomarkers [will be measured throughout the 12 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00570752
Other Study ID Numbers:
  • IM119-014
First Posted:
Dec 11, 2007
Last Update Posted:
Dec 7, 2015
Last Verified:
Nov 1, 2015
Additional relevant MeSH terms:
Vascular Diseases
Atorvastatin

Study Results

No Results Posted as of Dec 7, 2015