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

January 31, 2017 updated by: Forest Laboratories

A Randomized, Double-Blind Comparison of Apadenoson and Adenosine to Treadmill Exercise Stress for Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Local Institution
    • California
      • Santa Rosa, California, United States, 95405
        • Local Institution
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Local Institution
      • Guilford, Connecticut, United States, 06437
        • Local Institution
    • Delaware
      • Newark, Delaware, United States, 19713
        • Local Institution
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Local Institution
      • Gainsville, Florida, United States, 32605
        • Local Institution
      • Jacksonville, Florida, United States, 32207
        • Local Institution
      • Jacksonville, Florida, United States, 32258
        • Local Institution
      • Jacksonville Beach, Florida, United States, 32250
        • 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
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Local Institution
    • Illinois
      • 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
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Local Institution
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Local Institution
    • Maine
      • Auburn, Maine, United States, 04210
        • Local Institution
    • Maryland
      • Westminster, Maryland, United States, 21157
        • Local Institution
    • Minnesota
      • St. Louis Park, Minnesota, United States, 54416
        • Local Institution
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Local Institution
    • New York
      • Albany, New York, United States, 12205
        • Local Institution
      • West Islip, New York, United States, 11795
        • Local Institution
    • Ohio
      • 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
        • Local Institution
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Local Institution
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • Local Institution
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Local Institution
      • Johnson City, Tennessee, United States, 37604
        • Local Institution
    • Texas
      • Houston, Texas, United States, 77090
        • Local Institution
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Local Institution
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Agreement between MPI Summed Stress Scores for extent and severity of disease

Secondary Outcome Measures

Outcome Measure
Comparison of imaging data to 6 month event data or angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Robert Mittleman, MD, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (Estimate)

September 25, 2006

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS068645-305
  • EudraCT #2006-002222-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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