A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

Phase 3TerminatedNCT00162084

Forest Laboratories2,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

2,000

Conditions

Heart Disease Ischemic Heart Disease

Interventions

apadenosonDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (77)

Outcomes

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

Data from ClinicalTrials.gov

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Local Institution

Birmingham, Alabama, United States

Local Institution

Huntsville, Alabama, United States

Local Institution

North Little Rock, Arkansas, United States

Local Institution

Northridge, California, United States

Local Institution

Rancho Mirage, California, United States

Local Institution

Santa Clara, California, United States

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Santa Rosa, California, United States

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Walnut Creek, California, United States

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Bridgeport, Connecticut, United States

Local Institution

Guilford, Connecticut, United States

...and 67 more locations