Ischemic Heart Disease Clinical Trial
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
| Verified date | January 2017 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 2000 |
| Est. completion date | |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution | Albany | New York |
| United States | Local Institution | Amarillo | Texas |
| United States | Local Institution | Auburn | Maine |
| United States | Local Institution | Aurora | Illinois |
| United States | Local Institution | Ayer | Massachusetts |
| United States | Local Institution | Baton Rouge | Louisiana |
| United States | Local Institution | Birmingham | Alabama |
| United States | Local Institution | Bridgeport | Connecticut |
| United States | Local Institution | Chattanooga | Tennessee |
| United States | Local Institution | Cincinnati | Ohio |
| United States | Local Institution | Cleveland | Ohio |
| United States | Local Institution | Columbus | Ohio |
| United States | Local Institution | Fort Lauderdale | Florida |
| United States | Local Institution | Fort Wayne | Indiana |
| United States | Local Institution | Fox River Grove | Illinois |
| United States | Local Institution | Gainesville | Florida |
| United States | Local Institution | Gainesville | Florida |
| United States | Local Institution | Gainesville | Florida |
| United States | Local Institution | Grand Rapids | Michigan |
| United States | Local Institution | Guilford | Connecticut |
| United States | Local Institution | Honolulu | Hawaii |
| United States | Local Institution | Hopewell | Virginia |
| United States | Local Institution | Houston | Texas |
| United States | Local Institution | Huntsville | Alabama |
| United States | Local Institution | Indianapolis | Indiana |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution | Jacksonville Beach | Florida |
| United States | Local Institution | Johnson City | Tennessee |
| United States | Local Institution | Jupiter | Florida |
| United States | Local Institution | Kansas City | Missouri |
| United States | Local Institution | Kansas City | Missouri |
| United States | Local Institution | La Grange | Illinois |
| United States | Local Institution | Lorain | Ohio |
| United States | Local Institution | Louisville | Kentucky |
| United States | Local Institution | Lynchburg | Virginia |
| United States | Local Institution | Miami | Florida |
| United States | Local Institution | Minneapolis | Minnesota |
| United States | Local Institution | Nashville | Tennessee |
| United States | Local Institution | Nashville | Tennessee |
| United States | Local Institution | New Haven | Connecticut |
| United States | Local Institution | New York | New York |
| United States | Local Institution | Newark | Delaware |
| United States | Local Institution | North Little Rock | Arkansas |
| United States | Local Institution | Northridge | California |
| United States | Local Institution | Oak Ridge | Tennessee |
| United States | Local Institution | Overland Park | Kansas |
| United States | Local Institution | Peoria | Illinois |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Local Institution | Plano | Texas |
| United States | Local Institution | Providence | Rhode Island |
| United States | Local Institution | Raleigh | North Carolina |
| United States | Local Institution | Rancho Mirage | California |
| United States | Local Institution | Richmond | Virginia |
| United States | Local Institution | Roanoke | Virginia |
| United States | Local Institution | Safety Harbor | Florida |
| United States | Local Institution | Sandusky | Ohio |
| United States | Local Institution | Santa Clara | California |
| United States | Local Institution | Santa Rosa | California |
| United States | Local Institution | Scarborough | Maine |
| United States | Local Institution | Simpsonville | South Carolina |
| United States | Local Institution | South Portland | Maine |
| United States | Local Institution | Spokane | Washington |
| United States | Local Institution | St. Cloud | Minnesota |
| United States | Local Institution | St. Louis | Missouri |
| United States | Local Institution | St. Louis Park | Minnesota |
| United States | Local Institution | Stuart | Florida |
| United States | Local Institution | Tamarac | Florida |
| United States | Local Institution | Tulsa | Oklahoma |
| United States | Local Institution | Tupelo | Mississippi |
| United States | Local Institution | Walnut Creek | California |
| United States | Local Institution | Wausau | Wisconsin |
| United States | Local Institution | West Islip | New York |
| United States | Local Institution | Westlake | Ohio |
| United States | Local Institution | Westminster | Maryland |
| United States | Local Institution | Winfield | Illinois |
| United States | Local Institution | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete | |||
| Secondary | 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 |
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