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Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
This study is currently recruiting participants.
Study NCT00570752   Information provided by Bristol-Myers Squibb
First Received: December 10, 2007   Last Updated: November 4, 2009   History of Changes

December 10, 2007
November 4, 2009
December 2008
August 2010   (final data collection date for primary outcome measure)
FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ] [ Designated as safety issue: No ]
FDG-PET signal of the carotid and/or ascending aorta [ Time Frame: at 4 and 12 weeks ]
Complete list of historical versions of study NCT00570752 on ClinicalTrials.gov Archive Site
Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ] [ Designated as safety issue: No ]
Inflammatory and thrombotic biomarkers [ Time Frame: will be measured throughout the 12 weeks of treatment ]
 
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
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

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

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Vascular Diseases
  • Drug: Placebo + background low to moderate dose statin
  • Drug: BMS-582949 + Background low to moderate dose statin
  • Drug: Atorvastatin
  • Active Comparator: Placebo
  • Experimental: Active Comparator
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
72
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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.
United States
 
NCT00570752
Study Director, Bristol-Myers Squibb
IM119-014
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP