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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

April 8, 2008

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00162084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Heart Disease
Ischemic Heart Disease

Intervention ^†

Drug: apadenoson

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

2000

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162084

Responsible Party

Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging

Secondary IDs ^††

Study Sponsor ^†

Lantheus Medical Imaging

Collaborators ^††

Investigators ^†

Study Director:

Mark Hibberd, MD, PhD

Bristol-Myers Squibb

Information Provided By

Lantheus Medical Imaging

Verification Date

April 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.