drugset / Trial / NCT00862641

A Study of the Safety and Tolerance of Regadenoson in Subjects With Asthma or Chronic Obstructive Pulmonary Disease

NCT00862641 ↗

Phase 4 Completed 1009 enrolled Astellas Pharma Inc
RandomizedParallel-groupDouble-blindDiagnostic

Summary

This study is intended to determine the safety and tolerance of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

Timeline

Start
2009-04
Primary completion
2009-10
Completion
2009-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo - Asthma vs Regadenoson - Asthma; p = 0.1451; Cochran-Mantel-Haenszel NCT00862641 ↗

registry analysis (superiority or other test); Placebo - COPD vs Regadenoson - COPD; p = 0.5790; Cochran-Mantel-Haenszel NCT00862641 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Regadenoson Diagnostic / imaging agent 0.4 mg Intravenous