Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT00246935
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2005-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: