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Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00570752
First received: December 10, 2007
Last updated: March 23, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Vascular Diseases
Drug: Placebo + background low to moderate dose statin
Drug: BMS-582949 + Background low to moderate dose statin
Drug: Atorvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Placebo
Drug: Placebo + background low to moderate dose statin
Tablets, Oral, 0 mg, once daily, for 12 weeks
Experimental: B
Active Comparator
Drug: BMS-582949 + Background low to moderate dose statin
Tablets, Oral, 100 mg, once daily for 12 weeks
Active Comparator: C Drug: Atorvastatin
Tablets, oral, 80 mg once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570752

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00570752     History of Changes
Other Study ID Numbers: IM119-014
Study First Received: December 10, 2007
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014