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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666704
First Posted: August 16, 2012
Last Update Posted: June 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
August 14, 2012
August 16, 2012
June 21, 2013
April 2014
October 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01666704 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 ]
Same as current
Not Provided
Not Provided
 
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
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
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atherosclerotic Cardiovascular Disease
  • Drug: BMS-823778
    Capsules, Oral, 2mg, Once daily, 1 year
  • Drug: BMS-823778
    Capsules, Oral, 15mg, Once daily, 1 year
  • Drug: Placebo matching with BMS-823778
    Capsules, Oral, 0mg, Once daily, 1 year
  • Experimental: Treatment A: BMS-823778 (2mg)
    Intervention: Drug: BMS-823778
  • Experimental: Treatment B: BMS-823778 (15mg)
    Intervention: Drug: BMS-823778
  • Placebo Comparator: Treatment C: Placebo
    Intervention: Drug: Placebo matching with BMS-823778
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2016
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01666704
MB121-010
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2013

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