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

This study has been terminated.
(Business decision to end program)
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00380198
First received: September 21, 2006
Last updated: January 18, 2011
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Drug: Apadenoson
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

Drug Information available for: Adenosine
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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

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

Estimated Enrollment: 1500
Study Start Date: July 2006
Estimated Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

  • Contraindication to adenosine stress or inability to perform treadmill exercise test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380198

  Hide Study Locations
Locations
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
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Guilford, Connecticut, United States, 06437
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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Gainsville, Florida, United States, 32605
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32258
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Jacksonville Beach, Florida, United States, 32250
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Jupiter, Florida, United States, 33458
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Miami, Florida, United States, 33173
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Stuart, Florida, United States, 34996
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Tamarac, Florida, United States, 33321
United States, Hawaii
Local Institution
Honolulu, Hawaii, United States, 96813
United States, Illinois
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Aurora, Illinois, United States, 60504
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Bannockburn, Illinois, United States, 60015
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LaGrange, Illinois, United States, 60525
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Lombard, Illinois, United States, 60148
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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
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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, 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
Investigators
Study Director: Robert Mittleman, MD Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Amy Lankford, PhD, Sr. Manager, PGxHealth, LLC
ClinicalTrials.gov Identifier: NCT00380198     History of Changes
Other Study ID Numbers: BMS068645-305, EudraCT #2006-002222-31
Study First Received: September 21, 2006
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013