Back to resultsA Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography
Primary Purpose
Heart Disease, Ischemic Heart Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
apadenoson
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Disease
Eligibility Criteria
Inclusion Criteria: Referral for pharmacologic stress SPECT MPI Have suspected Ischemic heart disease Exclusion Criteria: Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment Severe asthma or COPD
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Outcomes
Primary Outcome Measures
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary Outcome Measures
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
Full Information
NCT ID
NCT00162084
First Posted
September 9, 2005
Last Updated
January 31, 2017
Sponsor
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00162084
Brief Title
A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography
Official Title
A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Business decision to stop the program
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Ischemic Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
apadenoson
Primary Outcome Measure Information:
Title
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary Outcome Measure Information:
Title
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referral for pharmacologic stress SPECT MPI
Have suspected Ischemic heart disease
Exclusion Criteria:
Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
Severe asthma or COPD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hibberd, MD, PhD
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Local Institution
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Local Institution
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Local Institution
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Local Institution
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Local Institution
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
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
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Local Institution
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Local Institution
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
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
32257
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
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Local Institution
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
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Local Institution
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
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United States
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Local Institution
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Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
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United States
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Local Institution
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Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
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Local Institution
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Fox River Grove
State/Province
Illinois
ZIP/Postal Code
60021
Country
United States
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Local Institution
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
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Local Institution
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Local Institution
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
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Local Institution
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
48604
Country
United States
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Local Institution
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
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Local Institution
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Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
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United States
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Local Institution
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
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United States
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Local Institution
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Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
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United States
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Local Institution
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Auburn
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Maine
ZIP/Postal Code
04210
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United States
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Local Institution
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Scarborough
State/Province
Maine
ZIP/Postal Code
04074
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United States
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Local Institution
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South Portland
State/Province
Maine
ZIP/Postal Code
04106
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United States
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Local Institution
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Westminster
State/Province
Maryland
ZIP/Postal Code
21157
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United States
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Local Institution
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Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
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United States
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Local Institution
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
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United States
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Local Institution
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
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United States
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Local Institution
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St. Cloud
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Minnesota
ZIP/Postal Code
56303
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United States
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Local Institution
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St. Louis Park
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Minnesota
ZIP/Postal Code
55416
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United States
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Local Institution
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Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
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Local Institution
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Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
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United States
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Local Institution
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Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
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Local Institution
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
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Local Institution
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Albany
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
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
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Local Institution
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
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Local Institution
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
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Local Institution
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
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Local Institution
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
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
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Local Institution
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Local Institution
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Local Institution
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Local Institution
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
Facility Name
Local Institution
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
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Local Institution
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Local Institution
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24015
Country
United States
Facility Name
Local Institution
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography
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