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

Phase 3

Terminated

• Conditions: Heart Disease; Ischemic Heart Disease

• Registration Number: NCT00162084
• Lead Sponsor: Forest Laboratories

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2006-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Wausau, Wisconsin, United States