A Comparison Study of Apadenoson and Adenosine to Treadmill Exercise Stress.

This study has been terminated.
(Business decision to end program)
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00380198
First received: September 21, 2006
Last updated: January 18, 2011
Last verified: April 2008
  Purpose

The purpose of this clinical research study is to compare Apadenoson and adenosine to treadmill exercise stress SPECT MPI


Condition Intervention Phase
Coronary Artery Disease
Drug: Apadenoson
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: A Randomized, Double-Blind Comparison of Apadenoson and Adenosine to Treadmill Exercise Stress for Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Agreement between MPI Summed Stress Scores for extent and severity of disease

Secondary Outcome Measures:
  • Comparison of imaging data to 6 month event data or angiography

Estimated Enrollment: 1500
Study Start Date: July 2006
Estimated Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Clinically appropriate for exercise stress testing

Exclusion Criteria:

  • Contraindication to adenosine stress or inability to perform treadmill exercise test
  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: NCT00380198

  Show 42 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Robert Mittleman, MD Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Amy Lankford, PhD, Sr. Manager, PGxHealth, LLC
ClinicalTrials.gov Identifier: NCT00380198     History of Changes
Other Study ID Numbers: BMS068645-305, EudraCT #2006-002222-31
Study First Received: September 21, 2006
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
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 July 22, 2014