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Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa.

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Trial Profile

Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa.

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

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At a glance

  • Drugs Amikacin (Primary)
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Insmed

    • Most Recent Events

    • 11 Jan 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov record.
    • 22 Aug 2012 Status changed from suspended to not yet recruiting as reported by ClinicalTrials.gov.
    • 08 May 2012 The US FDA lifts the clinical hold on inhaled amikacin, but the status of this trial is being evaluated by Insmed.

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