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A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)

Trial Profile

A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Mometasone (Primary) ; Mometasone
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.; Organon; Schering-Plough

Most Recent Events

  • 07 Mar 2016 Primary endpoint has been met. (Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]), according to results presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
  • 07 Mar 2016 Results presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
  • 05 Feb 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.

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