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Trials / Completed

CompletedNCT00246922

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
150 (planned)
Sponsor
AstraZeneca · Industry
Sex
All
Age
20 Years – 71 Years
Healthy volunteers
Not accepted

Summary

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Conditions

Interventions

TypeNameDescription
DRUGRoflumilast

Timeline

Start date
2004-12-01
Primary completion
2007-01-01
Completion
2007-10-01
First posted
2005-11-01
Last updated
2026-02-18

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT00246922. Inclusion in this directory is not an endorsement.

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217 (NCT00246922) · Clinical Trials Directory