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Clinical trial

A Multicenter, Randomized, Double-blind Phase 3 Study to Evaluate Tolerability and Pharmacokinetics of 500 μg Roflumilast Once Daily With an Up-titration Regimen in COPD, Including an Open-label Down-titration Period Evaluating Tolerability and Pharmacokinetics of 250 μg Roflumilast Once Daily in Subjects Not Tolerating 500 μg Roflumilast Once-daily

NCT02165826 is registered in ClinicalTrials.gov with AstraZeneca as lead sponsor.

NCT NCT02165826
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Registry record

As filed in ClinicalTrials.gov.

Title
A Multicenter, Randomized, Double-blind Phase 3 Study to Evaluate Tolerability and Pharmacokinetics of 500 μg Roflumilast Once Daily With an Up-titration Regimen in COPD, Including an Open-label Down-titration Period Evaluating Tolerability and Pharmacokinetics of 250 μg Roflumilast Once Daily in Subjects Not Tolerating 500 μg Roflumilast Once-daily
Lead sponsor
AstraZeneca
Phase
Phase 3
Overall status
Completed
Start date
May 1, 2014
Completion date
September 1, 2015
Enrollment
1,323 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

chronic obstructive pulmonary disease (copd)