Suspended

BMS-823778's Impact on Atherosclerotic Plaque Inflammation in Cardiovascular Disease

Study Aim

This study aims to evaluate the impact of BMS-823778, compared to a placebo, on reducing inflammation in atherosclerotic plaque within the carotid arteries and/or ascending aorta, as measured by positron emission tomography (PET) imaging.

What is being tested

Daily Oral Capsule: BMS-823778

+ Daily Oral Capsule: BMS-823778

+ Placebo Pills Matching BMS-823778

Drug

Who is being recruted

Arterial Occlusive Diseases+2

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 80 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2014

See protocol details

Summary

Principal SponsorBristol-Myers Squibb

Last updated: June 21, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of a drug called BMS-823778 on inflammation in patients with Atherosclerotic Cardiovascular Disease, a condition where plaque builds up inside the arteries. The main goal is to see if this drug can reduce inflammation in the plaque. This research is important as it could potentially lead to new treatments for managing this disease and improving heart health.

NCT01666704

Principal SponsorBristol-Myers Squibb

Last updated: June 21, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesAtherosclerosis

Criteria

3 inclusion criteria required to participate

Clinically stable at time of screening and randomization

Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event

On stable statin dose

2 exclusion criteria prevent from participating

Medical conditions that would impact the absorption of the study drug

Women of child bearing potential

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers