Status:
COMPLETED
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 chronic obstructive pulmonary disease (COPD) who completed the 24-week ...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Patients with chronic obstructive pulmonary disease (COPD)
- Written informed consent
- Patients who completed the 24-week evaluation of study APTA-2217-06
- Main exclusion criteria:
- If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day
- Patients with long-term oxygen therapy
- Serious diseases
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00246935
Start Date
May 1 2005
End Date
October 1 2007
Last Update
October 26 2016
Active Locations (1)
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1
Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan