Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250679
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2005-11-04
Brief Title:
Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
Multicenter Double-Blind Double-Dummy Randomized Active-Controlled Parallel Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in Subjects With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2012-05
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:
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease COPD
Detailed Description:
This is a double-blind double-dummy multicenter randomized active-controlled parallel group outpatient safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD Study participation will be over approximately 6 months This study was previously posted by Sepracor Inc In October 2009 Sepracor Inc was acquired by Dainippon Sumitomo Pharma and in October 2010 Sepracor Incs name was changed to Sunovion Pharmaceuticals Inc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None