drugset / Trial / NCT00442338

Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

NCT00442338 ↗

Phase 3 Completed 91 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

Summary

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Timeline

Start
2007-03
Primary completion
2007-08
Completion
2007-08

Outcome

Missed primary endpoint

registry analysis (unspecified test); Montelukast 7 mg vs Aminophylline 250 mg; p = 0.871; Difference in LS Means 0.01 (95% CI -0.07 to 0.08); ANCOVA NCT00442338 ↗

registry analysis (unspecified test); Montelukast 14 mg vs Aminophylline 250 mg; p = 0.794; Difference in LS Means -0.01 (95% CI -0.08 to 0.06); ANCOVA NCT00442338 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aminophylline Small molecule 250 mg Intravenous
Subject Montelukast Other / unclassified 7 mg Intravenous
Subject Montelukast Other / unclassified 14 mg Intravenous

Indications