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

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

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)

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

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

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

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

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 05, 2016