Vascular DiseasesPhase 2NCT00570752
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
A Phase 2 study testing BMS-582949, Atorvastatin and Statin in people with Vascular Diseases, run by Bristol-Myers Squibb at 17 sites in United States.
Trial summary
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- BMS-582949, Atorvastatin and Statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2008to Dec 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of documented atherosclerosis
- LDL between 70 and 130 mg/dL
- Patients receiving stable low- to moderate-dose statin
- BMI 18-37 kg/m²
- Must be able to swallow tablets
- Must be able to medically tolerate the procedures, contrast medium, and medications involved
Who cannot join
- Statin intolerance
- Renal impairment (serum creatinine > 1.5 mg/dL)
- History of chronic viral hepatitis or other liver dysfunction
- Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Mgh Cardiac Mr Pet Ct Program
Boston, Massachusetts, 02114
Southeast Clinical Research, Llc
Chiefland, Florida, 32626
Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio, 45212
Sterling Research Group
Cincinnati, Ohio, 45219
Radiant Research, Inc.
Dallas, Texas, 75231
Radiant Research, Inc.
Edina, Minnesota, 55435
Baylor College Of Medicine
Houston, Texas, 77030
Phillip D. Toth, Md
Indianapolis, Indiana, 46260
Jacksonville Center For Clinical Research - Univ Campus
Jacksonville, Florida, 32216
L-Marc Research Center
Louisville, Kentucky, 40213
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, 42431
Mcallen Heart Clinic
McAllen, Texas, 78503
Mount Sinai School Of Medicine Imaging Science Laboratories
New York, New York, 10029
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Lipid Center
Statesville, North Carolina, 28677
Florida Cardiovascular Institute
Tampa, Florida, 33609
Troy Internal Medince Pc/Research
Troy, Michigan, 48098
About this study
Official title: A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
- Conditions
- Vascular Diseases
- Being tested
- Placebo, BMS-582949, Atorvastatin, Statin
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
BMS-582949Drug
AtorvastatinDrug
StatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo + background low to moderate dose statin | Active comparator | Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks Receives: Other: Placebo; Drug: Statin |
| BMS-582949 + Background low to moderate dose statin | Experimental | BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks Receives: Drug: BMS-582949; Drug: Statin |
| Atorvastatin | Active comparator | Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG-PET signal of the carotid and/or ascending aorta
Measured: at 4 and 12 weeks
Secondary outcomes (1)
Inflammatory and thrombotic biomarkers
Measured: will be measured throughout the 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 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
- NCT00570752
- Sponsor's protocol ID
- IM119-014
- Status last verified
- Nov 2015
- First submitted
- 10 Dec 2007
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28.
PubMed 25913664
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients
- ClinicalTrials.gov ID
- NCT00570752
- Acronym / sponsor ID
- IM119-014
- Conditions
- Vascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Dec 2007 (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 determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + background low to moderate dose statin | Active comparator | Other: Placebo, Drug: StatinPlacebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks |
| BMS-582949 + Background low to moderate dose statin | Experimental | Drug: BMS-582949, Drug: StatinBMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks |
| Atorvastatin | Active comparator | Drug: AtorvastatinAtorvastatin Tablets, oral, 80 mg once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of documented atherosclerosis
- LDL between 70 and 130 mg/dL
- Patients receiving stable low- to moderate-dose statin
- BMI 18-37 kg/m²
- Must be able to swallow tablets
Key exclusion criteria (4 listed)
- Statin intolerance
- Renal impairment (serum creatinine > 1.5 mg/dL)
- History of chronic viral hepatitis or other liver dysfunction
- Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
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 |
|---|---|---|
| Placebo | Other | Placebo + background low to moderate dose statin |
| BMS-582949 | Drug | BMS-582949 + Background low to moderate dose statin |
| Atorvastatin | Drug | Atorvastatin |
| Statin | Drug | BMS-582949 + Background low to moderate dose statin, Placebo + background low to moderate dose statin |
Primary outcome
FDG-PET signal of the carotid and/or ascending aorta
Time frame: at 4 and 12 weeks
1 secondary outcome
Inflammatory and thrombotic biomarkers
Time frame: will be measured throughout the 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Derived from this study: PubMed 25913664Emami H, Vucic E, Subramanian S, Abdelbaky A, Fayad ZA, Du S, Roth E, Ballantyne CM, Mohler ER, Farkouh ME, Kim J, Farmer M, Li L, Ehlgen A, Langenickel TH, Velasquez L, Hayes W, Tawakol A. The effect of BMS-582949, a P38 mitogen-activated protein kinase (P38 MAPK) inhibitor on arterial inflammation: a multicenter FDG-PET trial. Atherosclerosis. 2015 Jun;240(2):490-6. doi: 10.1016/j.atherosclerosis.2015.03.039. Epub 2015 Mar 28.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-582949, Atorvastatin and Statin in people with Vascular Diseases, run by Bristol-Myers Squibb at 17 sites in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FDG-PET signal of the carotid and/or ascending aorta (time frame: at 4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00570752, which also lists 1 linked publication.
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 7 Dec 2015.