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

Condition	Intervention	Phase
Heart Disease Ischemic Heart Disease	Drug: apadenoson	Phase III

Further Study Details: 

Primary Outcomes: Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete
Secondary Outcomes: 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
Expected Total Enrollment:  2000

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00162084

BMS Call Center      866-892-1BMS  Ext. 204 

Alabama
      Local Institution, Huntsville,  Alabama,  35801,  United States; Recruiting
      Local Institution, Birmingham,  Alabama,  35213,  United States; Recruiting
California
      Local Institution, Rancho Mirage,  California,  92270,  United States; Recruiting
      Local Institution, Walnut Creek,  California,  94598,  United States; Recruiting
      Local Institution, Santa Rosa,  California,  95405,  United States; Recruiting
      Local Institution, Santa Rosa,  California,  95405,  United States; Recruiting
Connecticut
      Local Institution, New Haven,  Connecticut,  06510,  United States; Recruiting
      Local Institution, Guilford,  Connecticut,  06437,  United States; Recruiting
Delaware
      Local Institution, Newark,  Delaware,  19713,  United States; Recruiting
Florida
      Local Institution, Miami,  Florida,  33173,  United States; Recruiting
      Local Institution, Tamarac,  Florida,  33321,  United States; Recruiting
Hawaii
      Local Institution, Honolulu,  Hawaii,  96817,  United States; Recruiting
Illinois
      Local Institution, Winfield,  Illinois,  60190,  United States; Recruiting
      Local Institution, Peoria,  Illinois,  61603,  United States; Recruiting
      Local Institution, Aurora,  Illinois,  60504,  United States; Recruiting
Kansas
      Local Institution, Overland Park,  Kansas,  66209,  United States; Recruiting
Kentucky
      Local Institution, Louisville,  Kentucky,  40205,  United States; Recruiting
Louisiana
      Local Institution, Baton Rouge,  Louisiana,  70808,  United States; Recruiting
Maine
      Local Institution, Scarborough,  Maine,  04074,  United States; Recruiting
      Local Institution, South Portland,  Maine,  04106,  United States; Recruiting
      Local Institution, Auburn,  Maine,  04210,  United States; Recruiting
Maryland
      Local Institution, Westminster,  Maryland,  21157,  United States; Recruiting
Michigan
      Local Institution, Grand Rapids,  Michigan,  49525,  United States; Recruiting
Minnesota
      Local Institution, St. Louis Park,  Minnesota,  55416,  United States; Recruiting
      Local Institution, Minneapolis,  Minnesota,  55415,  United States; Recruiting
      Local Institution, St. Cloud,  Minnesota,  56303,  United States; Recruiting
Missouri
      Local Institution, St. Louis,  Missouri,  63104,  United States; Recruiting
New York
      Local Institution, West Islip,  New York,  11795,  United States; Recruiting
      Local Institution, Albany,  New York,  10025,  United States; Recruiting
Ohio
      Local Institution, Columbus,  Ohio,  43210,  United States; Recruiting
      Local Institution, Lorain,  Ohio,  44053,  United States; Recruiting
      Local Institution, Westlake,  Ohio,  44145,  United States; Recruiting
      Local Institution, Sandusky,  Ohio,  44870,  United States; Recruiting
Oklahoma
      Local Institution, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Pennsylvania
      Local Institution, Wyomissing,  Pennsylvania,  19610,  United States; Recruiting
      Local Institution, Philadelphia,  Pennsylvania,  19102,  United States; Recruiting
Rhode Island
      Local Institution, Providence,  Rhode Island,  02904,  United States; Recruiting
Tennessee
      Local Institution, Nashville,  Tennessee,  37203,  United States; Recruiting
      Local Institution, Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Local Institution, Nashville,  Tennessee,  37205,  United States; Recruiting
      Local Institution, Oak Ridge,  Tennessee,  37830,  United States; Recruiting
Wisconsin
      Local Institution, Wausau,  Wisconsin,  54401,  United States; Recruiting

Study chairs or principal investigators

Mark Hibberd, MD, PhD,  Study Director,  Bristol-Myers Squibb   

Study ID Numbers:  BMS068645-302
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162084
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13