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

June 19, 2013 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A: BMS-823778 (2mg)
Drug: BMS-823778
Capsules, Oral, 2mg, Once daily, 1 year
Drug: BMS-823778
Capsules, Oral, 15mg, Once daily, 1 year
Experimental: Treatment B: BMS-823778 (15mg)
Drug: BMS-823778
Capsules, Oral, 2mg, Once daily, 1 year
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 168

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 364
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
Approximately up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB121-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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