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
Phase of Trial: Phase III
Latest Information Update: 24 May 2017
At a glance
- Drugs Roflumilast (Primary)
- Indications Chronic obstructive pulmonary disease
- Focus Adverse reactions; Registrational
- Acronyms OPTIMIZE
- Sponsors Takeda; Takeda Europe Research & Development Centre
- 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.