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

This study has been terminated.

( Business decision to end program )

First Received on September 21, 2006. Last Updated on January 18, 2011 History of Changes

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00380198

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 III

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:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness

Drug Information available for: Adenosine Apadenoson

U.S. FDA Resources

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

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 February 09, 2012