Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014