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A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162084
Recruitment Status : Terminated (Business decision to stop the program)
First Posted : September 13, 2005
Last Update Posted : February 1, 2017
Sponsor:
Information provided by:
Forest Laboratories

Brief 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

Condition or disease Intervention/treatment Phase
Heart Disease Ischemic Heart Disease Drug: apadenoson Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
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
Study Start Date : April 2005
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine




Primary Outcome Measures :
  1. Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referral for pharmacologic stress SPECT MPI
  • Have suspected Ischemic heart disease

Exclusion Criteria:

  • Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
  • Severe asthma or COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162084


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Locations
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United States, Alabama
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Birmingham, Alabama, United States, 35213
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Huntsville, Alabama, United States, 35801
United States, Arkansas
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North Little Rock, Arkansas, United States, 72117
United States, California
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Northridge, California, United States, 91325
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Rancho Mirage, California, United States, 92270
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Santa Clara, California, United States, 95051
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Santa Rosa, California, United States, 95405
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Walnut Creek, California, United States, 94598
United States, Connecticut
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Bridgeport, Connecticut, United States, 06606
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Guilford, Connecticut, United States, 06437
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New Haven, Connecticut, United States, 06510
United States, Delaware
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Newark, Delaware, United States, 19713
United States, Florida
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Fort Lauderdale, Florida, United States, 33308
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Gainesville, Florida, United States, 32605
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Gainesville, Florida, United States, 32607
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Gainesville, Florida, United States, 32608
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Jacksonville Beach, Florida, United States, 32250
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32257
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Jupiter, Florida, United States, 33458
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Miami, Florida, United States, 33173
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Safety Harbor, Florida, United States, 34695
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Stuart, Florida, United States, 34996
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Tamarac, Florida, United States, 33321
United States, Hawaii
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Honolulu, Hawaii, United States, 96817
United States, Illinois
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Aurora, Illinois, United States, 60504
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Fox River Grove, Illinois, United States, 60021
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La Grange, Illinois, United States, 60525
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Peoria, Illinois, United States, 61603
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Winfield, Illinois, United States, 60190
United States, Indiana
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Fort Wayne, Indiana, United States, 48604
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Indianapolis, Indiana, United States, 46260
United States, Kansas
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Overland Park, Kansas, United States, 66209
United States, Kentucky
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Louisville, Kentucky, United States, 40205
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
United States, Maine
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Auburn, Maine, United States, 04210
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Scarborough, Maine, United States, 04074
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South Portland, Maine, United States, 04106
United States, Maryland
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Westminster, Maryland, United States, 21157
United States, Massachusetts
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Ayer, Massachusetts, United States, 01432
United States, Michigan
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Grand Rapids, Michigan, United States, 49525
United States, Minnesota
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Minneapolis, Minnesota, United States, 55415
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St. Cloud, Minnesota, United States, 56303
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St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Kansas City, Missouri, United States, 64132
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St. Louis, Missouri, United States, 63104
United States, New York
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Albany, New York, United States, 10025
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New York, New York, United States, 10029
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West Islip, New York, United States, 11795
United States, North Carolina
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Raleigh, North Carolina, United States, 27609
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44195
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Columbus, Ohio, United States, 43210
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Lorain, Ohio, United States, 44053
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Sandusky, Ohio, United States, 44870
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Westlake, Ohio, United States, 44145
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
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Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
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Providence, Rhode Island, United States, 02904
United States, South Carolina
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Simpsonville, South Carolina, United States, 29681
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Johnson City, Tennessee, United States, 37604
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37205
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Oak Ridge, Tennessee, United States, 37830
United States, Texas
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Amarillo, Texas, United States, 79106
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Houston, Texas, United States, 77090
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Plano, Texas, United States, 75024
United States, Virginia
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Hopewell, Virginia, United States, 23860
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Lynchburg, Virginia, United States, 24501
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Richmond, Virginia, United States, 23230
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Roanoke, Virginia, United States, 24015
United States, Washington
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Spokane, Washington, United States, 99204
United States, Wisconsin
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Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Mark Hibberd, MD, PhD Bristol-Myers Squibb

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Responsible Party: Amy Lankford, PhD, Sr. Manager, PGxHealth
ClinicalTrials.gov Identifier: NCT00162084     History of Changes
Other Study ID Numbers: BMS068645-302
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Adenosine
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action