A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

Phase 2

Terminated

• Conditions: Ischemic Heart Disease; Cardiovascular Disease

• Registration Number: NCT00162071
• Lead Sponsor: Forest Laboratories

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

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2006-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 New York, New York, United States