CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
montelukast sodium +1 moredrug
Likely dose
Montelukast sodium 7 mg or 14 mg single injectionAI-extracted
Key inclusion· 1
  • ✓Adult patients presenting with acute asthma attacks
Key exclusion· 3
  • ✕Any known or suspected acute or chronic pulmonary cause other than asthma (e.g., COPD, chronic heart failure)
  • ✕Smoking history of 20+ cigarettes per day for more than 15 years
  • ✕Significant disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe systemic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00229970
NCT00229970Phase 3Completed
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MK0476 Phase II/III Placebo Controlled Double Blind Study

Organon and Co·interventional·Posted Sep 30, 2005·Updated Feb 2, 2022

In Brief

A Phase 3 clinical trial evaluating montelukast sodium and Comparator: Placebo for Asthma. Completed, enrolled 225 participants.

Detailed Summary

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartSep 1, 2005
Primary CompletionOct 1, 2006
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

montelukast sodiumdrug

7 mg or 14 mg single injection

Comparator: Placebodrug

Placebo single injection