Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

NCT00570752 | Completed Phase 2 DMC

• 1 other identifier: IM119-014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

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

  at 4 and 12 weeks

Secondary Outcomes (1)

• Inflammatory and thrombotic biomarkers

  will be measured throughout the 12 weeks of treatment

Study Arms (3)

Placebo + background low to moderate dose statin

ACTIVE COMPARATOR

Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks

Other: Placebo; Drug: Statin

BMS-582949 + Background low to moderate dose statin

EXPERIMENTAL

BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks

Drug: BMS-582949; Drug: Statin

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks

Drug: Atorvastatin

Interventions

Placebo OTHER

Placebo + background low to moderate dose statin

BMS-582949 DRUG

BMS-582949 + Background low to moderate dose statin

Atorvastatin DRUG

Atorvastatin

Statin DRUG

BMS-582949 + Background low to moderate dose statin; Placebo + background low to moderate dose statin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

Southeast Clinical Research, Llc

Chiefland, Florida, 32626, United States

Location

Jacksonville Center For Clinical Research - Univ Campus

Jacksonville, Florida, 32216, United States

Location

Florida Cardiovascular Institute

Tampa, Florida, 33609, United States

Location

Phillip D. Toth, Md

Indianapolis, Indiana, 46260, United States

Location

L-Marc Research Center

Louisville, Kentucky, 40213, United States

Location

Commonwealth Biomedical Research, Llc

Madisonville, Kentucky, 42431, United States

Location

Mgh Cardiac Mr Pet Ct Program

Boston, Massachusetts, 02114, United States

Location

Troy Internal Medince Pc/Research

Troy, Michigan, 48098, United States

Location

Radiant Research, Inc.

Edina, Minnesota, 55435, United States

Location

Mount Sinai School Of Medicine Imaging Science Laboratories

New York, New York, 10029, United States

Location

The Lipid Center

Statesville, North Carolina, 28677, United States

Location

Metabolic And Atherosclerosis Research Center

Cincinnati, Ohio, 45212, United States

Location

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Radiant Research, Inc.

Dallas, Texas, 75231, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

Mcallen Heart Clinic

McAllen, Texas, 78503, United States

Location

Related Publications (1)

• Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28.

  PMID: 25913664 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Vascular Diseases

Interventions

4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamide; Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 7, 2015

Record last verified: 2015-11

Locations

US (17)