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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Atherosclerotic Cardiovascular Disease

Treatments: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

Study type: Interventional

Funder types: Industry

Identifiers

NCT01666704

MB121-010

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Treatment A: BMS-823778 (2mg)

Experimental group

Treatment:

Drug: BMS-823778

Treatment B: BMS-823778 (15mg)

Experimental group

Treatment:

Drug: BMS-823778

Treatment C: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching with BMS-823778