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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)
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00162071
First received: September 9, 2005
Last updated: January 31, 2017
Last verified: January 2017
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
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 as provided by Forest Laboratories:

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: 20
Study Start Date: July 2005
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162071

Locations
United States, New York
Local Institution
New York, New York, United States, 10025
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: E Gordon DePuey, MD St. Luke's-Roosevelt Hospital Center
  More Information

Responsible Party: Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162071     History of Changes
Other Study ID Numbers: BMS068645-203
Study First Received: September 9, 2005
Last Updated: January 31, 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 25, 2017