Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Trial Profile

Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2016

At a glance

  • Drugs Amikacin (Primary) ; Tobramycin
  • Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR-108
  • Sponsors Insmed
  • Most Recent Events

    • 01 Jul 2013 Status changed from active, no longer recruiting to completed, as reported by an Insmed media release.
    • 01 Jul 2013 Top-line results reported in an Insmed media release.
    • 01 Jul 2013 Primary endpoint 'Non-inferiority of amikacin vs tobramycin in change in forced expiratory volume in 1 second' has been met, according to an Insmed media release.
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