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

This study has been terminated.

( Business decision to stop the program )

First Received: September 9, 2005 Last Updated: April 8, 2008 History of Changes

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00162084

Purpose

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

MedlinePlus related topics: Heart Diseases

Drug Information available for: Adenosine Apadenoson

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

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

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

Estimated Enrollment:	2000
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162084

Show 77 Study Locations

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators

Study Director:

Mark Hibberd, MD, PhD

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, MD Sr. Medical Director )
Study ID Numbers:	BMS068645-302
Study First Received:	September 9, 2005
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00162084 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Stress

Ischemia
Congenital Abnormalities
Adenosine

Additional relevant MeSH terms:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009