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NCT00162071 Clinical Trial

A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00162071
Other study ID # BMS068645-203
Secondary ID
Status Terminated
Phase Phase 2
First received September 9, 2005
Last updated January 31, 2017
Start date July 2005

Study information
Verified date January 2017
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• apadenoson

Locations
Country Name City State
United States Local Institution New York New York

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 A comparison of adverse events will be conducted at the end of the study to assess safety.
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