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A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.

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. Identifier: NCT00380198
Recruitment Status : Terminated (Business decision to end program)
First Posted : September 25, 2006
Last Update Posted : February 1, 2017
Information provided by:
Forest Laboratories

Brief Summary:
The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Apadenoson Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
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)
Study Start Date : July 2006
Actual Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Primary Outcome Measures :
  1. Agreement between MPI Summed Stress Scores for extent and severity of disease

Secondary Outcome Measures :
  1. Comparison of imaging data to 6 month event data or angiography

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

  • Contraindication to adenosine stress or inability to perform treadmill exercise test

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 identifier (NCT number): NCT00380198

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United States, Alabama
Local Institution
Huntsville, Alabama, United States, 35801
United States, California
Local Institution
Santa Rosa, California, United States, 95405
United States, Connecticut
Local Institution
Bridgeport, Connecticut, United States, 06606
Local Institution
Guilford, Connecticut, United States, 06437
United States, Delaware
Local Institution
Newark, Delaware, United States, 19713
United States, Florida
Local Institution
Fort Lauderdale, Florida, United States, 33308
Local Institution
Gainsville, Florida, United States, 32605
Local Institution
Jacksonville Beach, Florida, United States, 32250
Local Institution
Jacksonville, Florida, United States, 32207
Local Institution
Jacksonville, Florida, United States, 32258
Local Institution
Jupiter, Florida, United States, 33458
Local Institution
Miami, Florida, United States, 33173
Local Institution
Stuart, Florida, United States, 34996
Local Institution
Tamarac, Florida, United States, 33321
United States, Hawaii
Local Institution
Honolulu, Hawaii, United States, 96813
United States, Illinois
Local Institution
Aurora, Illinois, United States, 60504
Local Institution
Bannockburn, Illinois, United States, 60015
Local Institution
LaGrange, Illinois, United States, 60525
Local Institution
Lombard, Illinois, United States, 60148
Local Institution
Winfield, Illinois, United States, 60190
United States, Indiana
Local Institution
Indianapolis, Indiana, United States, 46290
United States, Kansas
Local Institution
Overland Park, Kansas, United States, 66209
United States, Kentucky
Local Institution
Louisville, Kentucky, United States, 40205
United States, Louisiana
Local Institution
Baton Rouge, Louisiana, United States, 70808
United States, Maine
Local Institution
Auburn, Maine, United States, 04210
United States, Maryland
Local Institution
Westminster, Maryland, United States, 21157
United States, Minnesota
Local Institution
St. Louis Park, Minnesota, United States, 54416
United States, Mississippi
Local Institution
Tupelo, Mississippi, United States, 38801
United States, Missouri
Local Institution
Kansas City, Missouri, United States, 64132
United States, New York
Local Institution
Albany, New York, United States, 12205
Local Institution
West Islip, New York, United States, 11795
United States, Ohio
Local Institution
Cincinnati, Ohio, United States, 45219
Local Institution
Lorain, Ohio, United States, 44053
Local Institution
Sandusky, Ohio, United States, 44870
Local Institution
Westlake, Ohio, United States, 44145
United States, Pennsylvania
Local Institution
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Local Institution
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Local Institution
Chattanooga, Tennessee, United States, 37404
Local Institution
Johnson City, Tennessee, United States, 37604
United States, Texas
Local Institution
Houston, Texas, United States, 77090
United States, Virginia
Local Institution
Richmond, Virginia, United States, 23229
United States, Wisconsin
Local Institution
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Forest Laboratories
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Study Director: Robert Mittleman, MD Bristol-Myers Squibb

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Responsible Party: Amy Lankford, PhD, Sr. Manager, PGxHealth, LLC Identifier: NCT00380198    
Other Study ID Numbers: BMS068645-305
EudraCT #2006-002222-31
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
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