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A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500μg roflumilast once daily with an up-titration regimen in COPD, including an open-label down-titration period evaluating tolerability and pharmacokinetics of 250μg roflumilast once daily in subjects not tolerating 500μg roflumilast once-daily

Trial Profile

A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500μg roflumilast once daily with an up-titration regimen in COPD, including an open-label down-titration period evaluating tolerability and pharmacokinetics of 250μg roflumilast once daily in subjects not tolerating 500μg roflumilast once-daily

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

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At a glance

  • Drugs Roflumilast (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Registrational
  • Acronyms OPTIMIZE
  • Sponsors Takeda; Takeda Europe Research & Development Centre
  • Most Recent Events

    • 24 May 2017 Results of PK/PD modelling data, presented at the 113th International Conference of the American Thoracic Society.
    • 22 Oct 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 25 Aug 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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