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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01666704
First received: August 14, 2012
Last updated: June 19, 2013
Last verified: June 2013

August 14, 2012
June 19, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01666704
MB121-010
No
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