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Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, July 2009
First Received: December 10, 2007   Last Updated: November 16, 2009   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00570752
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment: 72
Study Start Date: December 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Placebo
Drug: Placebo + background low to moderate dose statin
Tablets, Oral, 0 mg, once daily, for 12 weeks
B: Experimental
Active Comparator
Drug: BMS-582949 + Background low to moderate dose statin
Tablets, Oral, 100 mg, once daily for 12 weeks
C: Active Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570752

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Florida
Jacksonville Center For Clinical Research - Univ Campus Recruiting
Jacksonville, Florida, United States, 32216
Contact: Ramon Castello, Site 010            
Local Institution Not yet recruiting
Chiefland, Florida, United States, 32626
Contact: Site 019            
United States, Kentucky
L-Marc Research Center Recruiting
Louisville, Kentucky, United States, 40213
Contact: Harold E. Bays, Site 013     502-515-5672        
Commonwealth Biomedical Research, Llc Recruiting
Madisonville, Kentucky, United States, 42431
Contact: Bret A. Wittmer, Site 014     270-825-8345        
United States, Massachusetts
Yawkey 5b, 5904 Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ahmed Tawakol, Site 001            
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: C. Oliver Wong, Site 007     248-898-4132        
Troy Internal Medince Pc/Research Recruiting
Troy, Michigan, United States, 48098
Contact: Neil Fraser, Site 016            
United States, Minnesota
University Of Minnesota - Cardiovascular Division Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Daniel Duprez, Site 011     612-626-4566        
United States, New York
Mount Sinai School Of Medicine Imaging Science Laboratories Recruiting
New York, New York, United States, 10029
Contact: Zahi Adel Fayad, Site 002            
United States, North Carolina
The Lipid Center Recruiting
Statesville, North Carolina, United States, 28677
Contact: James M. Rhyne, Site 008            
United States, Ohio
Metabolic And Atherosclerosis Research Center Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Evan A. Stein, Site 006            
Local Institution Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site 018            
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 012            
United States, Texas
Baylor College Of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Christie Ballantyne, Site 009            
Local Institution Not yet recruiting
Mc Allen, Texas, United States, 78503
Contact: Site 017            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: IM119-014
Study First Received: December 10, 2007
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00570752     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009