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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

Tracking Information
First Submitted Date  ICMJE September 21, 2006
First Posted Date  ICMJE September 25, 2006
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE July 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Agreement between MPI Summed Stress Scores for extent and severity of disease
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00380198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Comparison of imaging data to 6 month event data or angiography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.
Official Title  ICMJE A Randomized, Double-Blind Comparison of Apadenoson and Adenosine to Treadmill Exercise Stress for Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
Brief Summary The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Apadenoson
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 21, 2006)
1500
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

  • Contraindication to adenosine stress or inability to perform treadmill exercise test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380198
Other Study ID Numbers  ICMJE BMS068645-305
EudraCT #2006-002222-31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy Lankford, PhD, Sr. Manager, PGxHealth, LLC
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Mittleman, MD Bristol-Myers Squibb
PRS Account Forest Laboratories
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP