A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

This study has been terminated.

( Sponsor decided not to continue with the development 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:	NCT00162071

Purpose

The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.

Condition	Intervention	Phase
Cardiovascular Disease Ischemic Heart Disease	Drug: apadenoson	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	"A Phase II Open-Label, Non-Randomized, Single-Center Trial to Determine the Optimal Myocardial Perfusion Image Acquisition Time Following BMS068645 Administration

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

Drug Information available for: Apadenoson

U.S. FDA Resources

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

Measurements of Technetium Tc99m Sestamibi activity will be obtained from various regions of the body at the end of the study to determine optimal imaging times.

Secondary Outcome Measures:

A comparison of adverse events will be conducted at the end of the study to assess safety.

Estimated Enrollment:	20
Study Start Date:	July 2005

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older
Have known or suspected heart disease
Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days.
Weigh between 88 and 250 lbs.

Exclusion Criteria:

Allergic reaction to Technetium Tc99m Sestamibi or any of its components
History of asthma or lung disease
Ingestion of caffeinated substances within 12 hours prior to the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162071

Locations

United States, New York
Local Institution
New York, New York, United States, 10025

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators

Principal Investigator:

E Gordon DePuey, MD

St. Luke's-Roosevelt Hospital Center

More Information

No publications provided

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, MD Senior Medical Director )
Study ID Numbers:	BMS068645-203
Study First Received:	September 9, 2005
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00162071 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009