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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Atherosclerotic Cardiovascular Disease
Drug: BMS-823778
Drug: Placebo matching with BMS-823778
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: April 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666704

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01666704     History of Changes
Other Study ID Numbers: MB121-010
Study First Received: August 14, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 21, 2014