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OpenTrials
Completed

NCT Number: NCT00570752

Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

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

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southeast Clinical Research, Llc, Chiefland, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

BMS-582949

Drug

atorvastatin

Drug

Statin

Drug

Primary outcomes

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

    Time frame: at 4 and 12 weeks

Secondary outcomes

  1. Inflammatory and thrombotic biomarkers

    Time frame: will be measured throughout the 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2007
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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