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Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI

NCT01313572 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2012-05-01

No results posted yet for this study

Summary

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

Conditions

Interventions

DRUG

Apadenoson SPECT-MPI

Apadenoson single bolus IV injection 100 or 150 ug

DRUG

Adenosine SPECT-MPI

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • David B Bharucha, MD, PhD, FACC · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313572 on ClinicalTrials.gov