A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging - 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 ^†

July 2005

Current 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.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00162071 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

Official Title ^†

"A Phase II Open-Label, Non-Randomized, Single-Center Trial to Determine the Optimal Myocardial Perfusion Image Acquisition Time Following BMS068645 Administration

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Cardiovascular 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 ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162071

Responsible Party

Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging

Secondary IDs ^††

Study Sponsor ^†

Lantheus Medical Imaging

Collaborators ^††

Investigators ^†

Principal Investigator:

E Gordon DePuey, MD

St. Luke's-Roosevelt Hospital Center

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.