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Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis

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ClinicalTrials.gov Identifier: NCT01666704
Recruitment Status : Withdrawn
First Posted : August 16, 2012
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: BMS-823778 Drug: Placebo matching with BMS-823778 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Effects of BMS-823778 on Atherosclerotic Plaque Inflammation as Measured by Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET) in Patients With Atherosclerotic Cardiovascular Disease
Study Start Date : April 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment A: BMS-823778 (2mg) Drug: BMS-823778
Capsules, Oral, 2mg, Once daily, 1 year
Experimental: Treatment B: BMS-823778 (15mg) Drug: BMS-823778
Capsules, Oral, 15mg, Once daily, 1 year
Placebo Comparator: Treatment C: Placebo Drug: Placebo matching with BMS-823778
Capsules, Oral, 0mg, Once daily, 1 year



Primary Outcome Measures :
  1. The effect of BMS-823778 versus placebo on carotids and/or ascending aortic will be measured by fluorodeoxyglucose (FDG) uptake in the index vessel as by positron emission tomography (PET) imaging [ Time Frame: Day 168 ]

Secondary Outcome Measures :
  1. Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices) [ Time Frame: Day 364 ]
    Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices): total vessel area, wall area, wall thickness, and wall area/total vessel area ratio (normalized wall index), based on the average of the right and left carotids, measured by Magnetic Resonance Imaging (MRI)

  2. Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores [ Time Frame: Approximately up to 60 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
  • On stable statin dose
  • Clinically stable at time of screening and randomization

Exclusion Criteria:

  • Women of child bearing potential
  • Medical conditions that would impact the absorption of the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666704


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01666704     History of Changes
Other Study ID Numbers: MB121-010
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases