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Clinical Trial: A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging
This study is currently recruiting patients.
Verified by Bristol-Myers Squibb August 2005
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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 |
MedlinePlus related topics: Coronary Disease; Heart Diseases; Vascular Diseases
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
Further Study Details:
Primary Outcomes: 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 Outcomes: A comparison of adverse events will be conducted at the end of the study to assess safety.
Expected Total Enrollment: 20
Secondary Outcomes: A comparison of adverse events will be conducted at the end of the study to assess safety.
Expected Total Enrollment: 20
Study start: July 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00162071
BMS Call Center 866-892-1BMS Ext. 219
New York
Local Institution, New York, New York, 10025, United States; Recruiting
Study chairs or principal investigators
E Gordon DePuey, MD, Principal Investigator, St. Luke''''s-Roosevelt Hospital Center
More Information
Study ID Numbers: BMS068645-203
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162071
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162071
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Batten Disease (National Institute of Neurological Disorders and Stroke)
- Batten Disease (National Institute of Neurological Disorders and Stroke)
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