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)
Information provided by:
First received: September 9, 2005
Last updated: January 18, 2011
Last verified: April 2008
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.
Ischemic Heart Disease
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||"A Phase II Open-Label, Non-Randomized, Single-Center Trial to Determine the Optimal Myocardial Perfusion Image Acquisition Time Following BMS068645 Administration
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:
| Study Start Date:
| Primary Completion Date:
||March 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162071
|New York, New York, United States, 10025 |
||E Gordon DePuey, MD
||St. Luke's-Roosevelt Hospital Center
No publications provided
||Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 9, 2005
||January 18, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Coronary Artery Disease
Arterial Occlusive Diseases