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

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ClinicalTrials.gov Identifier: NCT00380198
Recruitment Status : Terminated (Business decision to end program)
First Posted : September 25, 2006
Last Update Posted : February 1, 2017
Sponsor:
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

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
U.S. FDA Resources




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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00380198


  Show 42 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Robert Mittleman, MD Bristol-Myers Squibb

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
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action