Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal