Heart DiseasePhase 3NCT00162084
A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography
A Phase 3 study testing apadenoson in people with Heart Disease and Ischemic Heart Disease, run by Forest Laboratories at 77 sites in United States.
Trial summary
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Ischemic Heart Disease
- What is being tested?
- apadenoson
- How many people
- 2,000 participants
- Where
- 77 sitesUnited States
- Study dates
- Apr 2005to Mar 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for pharmacologic stress SPECT MPI
- Have suspected Ischemic heart disease
Who cannot join
- Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
- Severe asthma or COPD
Trial locations and contacts
77 sites in 1 country.
77 sites in 1 country
United States77 sites
Local Institution
Albany, New York, 10025
Local Institution
Amarillo, Texas, 79106
Local Institution
Auburn, Maine, 04210
Local Institution
Aurora, Illinois, 60504
Local Institution
Ayer, Massachusetts, 01432
Local Institution
Baton Rouge, Louisiana, 70808
Local Institution
Birmingham, Alabama, 35213
Local Institution
Bridgeport, Connecticut, 06606
Local Institution
Chattanooga, Tennessee, 37404
Local Institution
Cincinnati, Ohio, 45219
Local Institution
Cleveland, Ohio, 44195
Local Institution
Columbus, Ohio, 43210
Local Institution
Fort Lauderdale, Florida, 33308
Local Institution
Fort Wayne, Indiana, 48604
Local Institution
Fox River Grove, Illinois, 60021
Local Institution
Gainesville, Florida, 32605
Local Institution
Gainesville, Florida, 32607
Local Institution
Gainesville, Florida, 32608
Local Institution
Grand Rapids, Michigan, 49525
Local Institution
Guilford, Connecticut, 06437
Local Institution
Honolulu, Hawaii, 96817
Local Institution
Hopewell, Virginia, 23860
Local Institution
Houston, Texas, 77090
Local Institution
Huntsville, Alabama, 35801
Local Institution
Indianapolis, Indiana, 46260
Local Institution
Jacksonville, Florida, 32207
Local Institution
Jacksonville, Florida, 32257
Local Institution
Jacksonville Beach, Florida, 32250
Local Institution
Johnson City, Tennessee, 37604
Local Institution
Jupiter, Florida, 33458
Local Institution
Kansas City, Missouri, 64111
Local Institution
Kansas City, Missouri, 64132
Local Institution
La Grange, Illinois, 60525
Local Institution
Lorain, Ohio, 44053
Local Institution
Louisville, Kentucky, 40205
Local Institution
Lynchburg, Virginia, 24501
Local Institution
Miami, Florida, 33173
Local Institution
Minneapolis, Minnesota, 55415
Local Institution
Nashville, Tennessee, 37203
Local Institution
Nashville, Tennessee, 37205
Local Institution
New Haven, Connecticut, 06510
Local Institution
New York, New York, 10029
Local Institution
Newark, Delaware, 19713
Local Institution
North Little Rock, Arkansas, 72117
Local Institution
Northridge, California, 91325
Local Institution
Oak Ridge, Tennessee, 37830
Local Institution
Overland Park, Kansas, 66209
Local Institution
Peoria, Illinois, 61603
Local Institution
Philadelphia, Pennsylvania, 19102
Local Institution
Plano, Texas, 75024
Local Institution
Providence, Rhode Island, 02904
Local Institution
Raleigh, North Carolina, 27609
Local Institution
Rancho Mirage, California, 92270
Local Institution
Richmond, Virginia, 23230
Local Institution
Roanoke, Virginia, 24015
Local Institution
Safety Harbor, Florida, 34695
Local Institution
Saint Cloud, Minnesota, 56303
Local Institution
Saint Louis Park, Minnesota, 55416
Local Institution
Sandusky, Ohio, 44870
Local Institution
Santa Clara, California, 95051
Local Institution
Santa Rosa, California, 95405
Local Institution
Scarborough, Maine, 04074
Local Institution
Simpsonville, South Carolina, 29681
Local Institution
South Portland, Maine, 04106
Local Institution
Spokane, Washington, 99204
Local Institution
St Louis, Missouri, 63104
Local Institution
Stuart, Florida, 34996
Local Institution
Tamarac, Florida, 33321
Local Institution
Tulsa, Oklahoma, 74104
Local Institution
Tupelo, Mississippi, 38801
Local Institution
Walnut Creek, California, 94598
Local Institution
Wausau, Wisconsin, 54401
Local Institution
West Islip, New York, 11795
Local Institution
Westlake, Ohio, 44145
Local Institution
Westminster, Maryland, 21157
Local Institution
Winfield, Illinois, 60190
Local Institution
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects
- Conditions
- Heart Disease, Ischemic Heart Disease
- Being tested
- apadenoson
- Medical subject headings
- Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apadenosonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary outcomes (1)
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2006
Why it stopped: Business decision to stop the program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Hibberd, MD, PhD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162084
- Sponsor's protocol ID
- BMS068645-302
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2005
- Last updated
- 1 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography
- ClinicalTrials.gov ID
- NCT00162084
- Acronym / sponsor ID
- BMS068645-302
- Conditions
- Heart Disease, Ischemic Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to stop the program
- Enrolment
- 2,000 participants
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Mar 2006 (actual)
- First posted
- 13 Sep 2005 (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 BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referral for pharmacologic stress SPECT MPI
- Have suspected Ischemic heart disease
Key exclusion criteria (2 listed)
- Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
- Severe asthma or COPD
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 |
|---|---|---|
| apadenoson | Drug | – |
Primary outcome
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
1 secondary outcome
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
Results and safety
The study was stopped early (reason given: Business decision to stop the program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Related trials for Heart Disease
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
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.
Mark Hibberd, MD, PhD study director
Bristol-Myers Squibb
77 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing apadenoson in people with Heart Disease and Ischemic Heart Disease, run by Forest Laboratories at 77 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 2 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: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Business decision to stop the program). Results are not available in the source record.
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?
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete. 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 1 Feb 2017.