NCT01666704

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

August 14, 2012

Last Update Submit

June 19, 2013

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 168

Secondary Outcomes (2)

  • Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)

    Day 364

  • Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores

    Approximately up to 60 weeks

Study Arms (3)

Treatment A: BMS-823778 (2mg)

EXPERIMENTAL
Drug: BMS-823778

Treatment B: BMS-823778 (15mg)

EXPERIMENTAL
Drug: BMS-823778

Treatment C: Placebo

PLACEBO COMPARATOR
Drug: Placebo matching with BMS-823778

Interventions

BMS-823778DRUG

Capsules, Oral, 2mg, Once daily, 1 year

Treatment A: BMS-823778 (2mg)
Placebo matching with BMS-823778DRUG

Capsules, Oral, 0mg, Once daily, 1 year

Treatment C: Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
  • On stable statin dose
  • Clinically stable at time of screening and randomization

You may not qualify if:

  • Women of child bearing potential
  • Medical conditions that would impact the absorption of the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Atherosclerosis

Interventions

BMS-823778

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

May 1, 2016

Last Updated

June 21, 2013

Record last verified: 2013-06