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| Name | Class |
|---|---|
| Tanabe Pharma Corporation | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) . |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy. |
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation | Osaka | Japan |
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| Label | URL |
|---|---|
| APTA-2217-08-RDS-2009-01-16.pdf | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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