Coronary Artery DiseasePhase 3NCT00380198
A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.
A Phase 3 study testing Apadenoson in people with Coronary Artery Disease, run by Forest Laboratories at 42 sites in United States.
Trial summary
The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Apadenoson
- How many people
- 1,500 participants
- Where
- 42 sitesUnited States
- Study dates
- Jul 2006to Nov 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
- Adult, Older adult
Who may be able to join
- Clinically appropriate for exercise stress testing
Who cannot join
- Contraindication to adenosine stress or inability to perform treadmill exercise test
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Local Institution
Albany, New York, 12205
Local Institution
Auburn, Maine, 04210
Local Institution
Aurora, Illinois, 60504
Local Institution
Bannockburn, Illinois, 60015
Local Institution
Baton Rouge, Louisiana, 70808
Local Institution
Bridgeport, Connecticut, 06606
Local Institution
Chattanooga, Tennessee, 37404
Local Institution
Cincinnati, Ohio, 45219
Local Institution
Fort Lauderdale, Florida, 33308
Local Institution
Gainsville, Florida, 32605
Local Institution
Guilford, Connecticut, 06437
Local Institution
Honolulu, Hawaii, 96813
Local Institution
Houston, Texas, 77090
Local Institution
Huntsville, Alabama, 35801
Local Institution
Indianapolis, Indiana, 46290
Local Institution
Jacksonville, Florida, 32207
Local Institution
Jacksonville, Florida, 32258
Local Institution
Jacksonville Beach, Florida, 32250
Local Institution
Johnson City, Tennessee, 37604
Local Institution
Jupiter, Florida, 33458
Local Institution
Kansas City, Missouri, 64132
Local Institution
LaGrange, Illinois, 60525
Local Institution
Lombard, Illinois, 60148
Local Institution
Lorain, Ohio, 44053
Local Institution
Louisville, Kentucky, 40205
Local Institution
Madison, Wisconsin, 53715
Local Institution
Miami, Florida, 33173
Local Institution
Newark, Delaware, 19713
Local Institution
Overland Park, Kansas, 66209
Local Institution
Richmond, Virginia, 23229
Local Institution
Saint Louis Park, Minnesota, 54416
Local Institution
Sandusky, Ohio, 44870
Local Institution
Santa Rosa, California, 95405
Local Institution
Simpsonville, South Carolina, 29681
Local Institution
Stuart, Florida, 34996
Local Institution
Tamarac, Florida, 33321
Local Institution
Tupelo, Mississippi, 38801
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 Randomized, Double-Blind Comparison of Apadenoson and Adenosine to Treadmill Exercise Stress for Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI
- Conditions
- Coronary Artery Disease
- Being tested
- Apadenoson
- Medical subject headings
- Coronary Artery Disease
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.
Agreement between MPI Summed Stress Scores for extent and severity of disease
Secondary outcomes (1)
Comparison of imaging data to 6 month event data or angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startJul 2006
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Business decision to end program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Crossover
- Masking
- Double blind
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Mittleman, MD, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380198
- Sponsor's protocol ID
- BMS068645-305
- Other IDs
- EudraCT #2006-002222-31
- Status last verified
- Jan 2017
- First submitted
- 21 Sep 2006
- 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 Randomized, Double-Blind Comparison of Apadenoson and Adenosine to Treadmill Exercise Stress for Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
- ClinicalTrials.gov ID
- NCT00380198
- Acronym / sponsor ID
- BMS068645-305
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to end program
- Enrolment
- 1,500 participants
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006
- First posted
- 25 Sep 2006 (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 this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically appropriate for exercise stress testing
Key exclusion criteria (1 listed)
- Contraindication to adenosine stress or inability to perform treadmill exercise test
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
Agreement between MPI Summed Stress Scores for extent and severity of disease
1 secondary outcome
Comparison of imaging data to 6 month event data or angiography
Results and safety
The study was stopped early (reason given: Business decision to end program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Robert Mittleman, MD study director
Bristol-Myers Squibb
42 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 Coronary Artery Disease, run by Forest Laboratories at 42 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 1 inclusion and 1 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 42 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 end 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?
Agreement between MPI Summed Stress Scores for extent and severity of disease. 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.