Atherosclerotic Cardiovascular DiseasePhase 2NCT01666704
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
A Phase 2 study testing BMS-823778 in people with Atherosclerotic Cardiovascular Disease, run by Bristol-Myers Squibb.
Trial summary
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- BMS-823778
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
- On stable statin dose
- Clinically stable at time of screening and randomization
Who cannot join
- Women of child bearing potential
- Medical conditions that would impact the absorption of the study drug
About this study
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
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- BMS-823778, Placebo matching with BMS-823778
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-823778Drug
Capsules, Oral, 2mg, Once daily, 1 year
BMS-823778Drug
Capsules, Oral, 15mg, Once daily, 1 year
Placebo matching with BMS-823778Drug
Capsules, Oral, 0mg, Once daily, 1 year
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-823778 (2mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Treatment B: BMS-823778 (15mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Treatment C: Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching with BMS-823778 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 168
Secondary outcomes (2)
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)
Measured: Day 364
Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores
Measured: Approximately up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startApr 2014
- Primary completionOct 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666704
- Sponsor's protocol ID
- MB121-010
- Status last verified
- Jun 2013
- First submitted
- 14 Aug 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01666704
- Acronym / sponsor ID
- MB121-010
- Conditions
- Atherosclerotic Cardiovascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented atherosclerotic cardiovascular disease or at high risk of cardiovascular event
- On stable statin dose
- Clinically stable at time of screening and randomization
Key exclusion criteria (2 listed)
- Women of child bearing potential
- Medical conditions that would impact the absorption of the study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-823778Capsules, Oral, 2mg, Once daily, 1 year | Drug | Treatment A: BMS-823778 (2mg) |
| BMS-823778Capsules, Oral, 15mg, Once daily, 1 year | Drug | Treatment B: BMS-823778 (15mg) |
| Placebo matching with BMS-823778Capsules, Oral, 0mg, Once daily, 1 year | Drug | Treatment C: Placebo |
Primary outcome
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
Time frame: Day 168
2 secondary outcomes
Structural changes in the arterial wall (absolute, percent change, and both, from baseline in four indices)
Time frame: Day 364
Safety will be measured by adverse event, vital signs, electrocardiogram, physical examinations, clinical laboratory tests and Ferriman- Gallwey scores
Time frame: Approximately up to 60 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-823778 in people with Atherosclerotic Cardiovascular Disease, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.