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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 18, 2011
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Drug Information available for: Adenosine
U.S. FDA Resources

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
Genders Eligible for Study:   Both
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
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

No publications provided

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 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013