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.
Withdrawn prior to enrolment
Phase of Trial: Phase III
Latest Information Update: 30 Sep 2017
At a glance
- Drugs Amikacin (Primary)
- Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Sponsors Insmed
- 11 Jan 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov record.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.