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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apadenoson
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

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

Sites / Locations

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Outcomes

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

Full Information

First Posted
September 21, 2006
Last Updated
January 31, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00380198
Brief Title
A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Business decision to end program
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
1500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Apadenoson
Primary Outcome Measure Information:
Title
Agreement between MPI Summed Stress Scores for extent and severity of disease
Secondary Outcome Measure Information:
Title
Comparison of imaging data to 6 month event data or angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Clinically appropriate for exercise stress testing Exclusion Criteria: Contraindication to adenosine stress or inability to perform treadmill exercise test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Mittleman, MD
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Local Institution
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Local Institution
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Local Institution
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Local Institution
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Local Institution
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Local Institution
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
Facility Name
Local Institution
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Local Institution
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Local Institution
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Local Institution
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Local Institution
City
Bannockburn
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Local Institution
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Local Institution
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Local Institution
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Local Institution
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Local Institution
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Local Institution
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Local Institution
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Local Institution
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
54416
Country
United States
Facility Name
Local Institution
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Local Institution
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Local Institution
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Local Institution
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Local Institution
City
Lorain
State/Province
Ohio
ZIP/Postal Code
44053
Country
United States
Facility Name
Local Institution
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Local Institution
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Local Institution
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Local Institution
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Local Institution
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Local Institution
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Local Institution
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Local Institution
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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

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