Post Marketing Surveillance of Roflumilast in Korea

Sponsor
AstraZeneca
Study ID
NCT02068456
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.

Key Dates

Start date
Sep 18, 2012
Status verified
Jun 2017
Primary completion
Apr 26, 2017
Completion
Apr 26, 2017

Study Design

Enrollment
1,837 participants (actual)

Arms

  • Arm: Roflumilast
    Roflumilast will be administered according to the prescribing information of the approved Korean label.

Primary Outcome Measure

Number of participants with adverse events and adverse drug reactions [ Time Frame: Baseline to at least 1 month after administration of Roflumilast . ]

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