Back to resultsA Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging
Primary Purpose
Cardiovascular Disease, Ischemic Heart Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apadenoson
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiovascular Disease
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
Sites / Locations
- Local Institution
Outcomes
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.
Full Information
NCT ID
NCT00162071
First Posted
September 9, 2005
Last Updated
January 31, 2017
Sponsor
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00162071
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided not to continue with the development program
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Ischemic Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
apadenoson
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
A comparison of adverse events will be conducted at the end of the study to assess safety.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Gordon DePuey, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging
We'll reach out to this number within 24 hrs