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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162084
Enrollment
2000
Registered
2005-09-13
Start date
2005-04-30
Completion date
Unknown
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Ischemic Heart Disease

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

Interventions

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026