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A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

This study has been terminated.
(Business decision to stop the program)
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00162084
First received: September 9, 2005
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects

Condition Intervention Phase
Heart Disease Ischemic Heart Disease Drug: apadenoson Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Diagnostic
Official Title: A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete

Secondary Outcome Measures:
  • Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board

Estimated Enrollment: 2000
Study Start Date: April 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:

  • Referral for pharmacologic stress SPECT MPI
  • Have suspected Ischemic heart disease

Exclusion Criteria:

  • Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
  • Severe asthma or COPD
  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: NCT00162084

  Show 77 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Mark Hibberd, MD, PhD Bristol-Myers Squibb
  More Information

Responsible Party: Amy Lankford, PhD, Sr. Manager, PGxHealth
ClinicalTrials.gov Identifier: NCT00162084     History of Changes
Other Study ID Numbers: BMS068645-302
Study First Received: September 9, 2005
Last Updated: January 31, 2017

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017