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

NCT ID: NCT01666704

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A: BMS-823778 (2mg)

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Treatment B: BMS-823778 (15mg)

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

Capsules, Oral, 15mg, Once daily, 1 year

Treatment C: Placebo

Group Type PLACEBO_COMPARATOR

Placebo matching with BMS-823778

Intervention Type DRUG

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

Interventions

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BMS-823778

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

Intervention Type DRUG

BMS-823778

Capsules, Oral, 15mg, Once daily, 1 year

Intervention Type DRUG

Placebo matching with BMS-823778

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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Other Identifiers

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MB121-010

Identifier Type: -

Identifier Source: org_study_id

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