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

This study is not yet open for participant recruitment.
Verified August 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01666704
First received: August 14, 2012
Last updated: March 28, 2013
Last verified: August 2012
History of Changes
  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:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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 ]

Estimated Enrollment: 180
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

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

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

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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: March 28, 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 May 22, 2013