Clinical trial NCT00162084: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Disease
Ischemic Heart Disease
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: North Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Northridge
country: United States
facility: Local Institution
state: California
city: Rancho Mirage
country: United States
facility: Local Institution
state: California
city: Santa Clara
country: United States
facility: Local Institution
state: California
city: Santa Rosa
country: United States
facility: Local Institution
state: California
city: Walnut Creek
country: United States
facility: Local Institution
state: California
city: Bridgeport
country: United States
facility: Local Institution
state: Connecticut
city: Guilford
country: United States
facility: Local Institution
state: Connecticut
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Fort Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Gainesville
country: United States
facility: Local Institution
state: Florida
city: Gainesville
country: United States
facility: Local Institution
state: Florida
city: Gainesville
country: United States
facility: Local Institution
state: Florida
city: Jacksonville Beach
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Jupiter
country: United States
facility: Local Institution
state: Florida
city: Miami
country: United States
facility: Local Institution
state: Florida
city: Safety Harbor
country: United States
facility: Local Institution
state: Florida
city: Stuart
country: United States
facility: Local Institution
state: Florida
city: Tamarac
country: United States
facility: Local Institution
state: Florida
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Aurora
country: United States
facility: Local Institution
state: Illinois
city: Fox River Grove
country: United States
facility: Local Institution
state: Illinois
city: La Grange
country: United States
facility: Local Institution
state: Illinois
city: Peoria
country: United States
facility: Local Institution
state: Illinois
city: Winfield
country: United States
facility: Local Institution
state: Illinois
city: Fort Wayne
country: United States
facility: Local Institution
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Overland Park
country: United States
facility: Local Institution
state: Kansas
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution
state: Louisiana
city: Auburn
country: United States
facility: Local Institution
state: Maine
city: Scarborough
country: United States
facility: Local Institution
state: Maine
city: South Portland
country: United States
facility: Local Institution
state: Maine
city: Westminster
country: United States
facility: Local Institution
state: Maryland
city: Ayer
country: United States
facility: Local Institution
state: Massachusetts
city: Grand Rapids
country: United States
facility: Local Institution
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: St. Cloud
country: United States
facility: Local Institution
state: Minnesota
city: St. Louis Park
country: United States
facility: Local Institution
state: Minnesota
city: Tupelo
country: United States
facility: Local Institution
state: Mississippi
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: St. Louis
country: United States
facility: Local Institution
state: Missouri
city: Albany
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: West Islip
country: United States
facility: Local Institution
state: New York
city: Raleigh
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Lorain
country: United States
facility: Local Institution
state: Ohio
city: Sandusky
country: United States
facility: Local Institution
state: Ohio
city: Westlake
country: United States
facility: Local Institution
state: Ohio
city: Tulsa
country: United States
facility: Local Institution
state: Oklahoma
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Wyomissing
country: United States
facility: Local Institution
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Simpsonville
country: United States
facility: Local Institution
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution
state: Tennessee
city: Johnson City
country: United States
facility: Local Institution
state: Tennessee
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
city: Oak Ridge
country: United States
facility: Local Institution
state: Tennessee
city: Amarillo
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Plano
country: United States
facility: Local Institution
state: Texas
city: Hopewell
country: United States
facility: Local Institution
state: Virginia
city: Lynchburg
country: United States
facility: Local Institution
state: Virginia
city: Richmond
country: United States
facility: Local Institution
state: Virginia
city: Roanoke
country: United States
facility: Local Institution
state: Virginia
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Wausau
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Mark Hibberd, MD, PhD
role: STUDY_DIRECTOR
References: