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

Atherosclerotic Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01666704
• Other study ID #: MB121-010
• Status: Withdrawn
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: June 19, 2013
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• BMS-823778
Capsules, Oral, 2mg, Once daily, 1 year
• BMS-823778
Capsules, Oral, 15mg, Once daily, 1 year
• Placebo matching with BMS-823778
Capsules, Oral, 0mg, Once daily, 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)	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	No
Secondary	Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores		Approximately up to 60 weeks	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form