Back to resultsLong-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Phosphodiesterase 4 inhibitor, Roflumilast
Eligibility 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
Sites / Locations
- Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation
Outcomes
Primary Outcome Measures
Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .
Secondary Outcome Measures
Efficacy.
Full Information
NCT ID
NCT00246935
First Posted
October 31, 2005
Last Updated
October 24, 2016
Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00246935
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)
Official Title
A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Phosphodiesterase 4 inhibitor, Roflumilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .
Secondary Outcome Measure Information:
Title
Efficacy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation
City
Osaka
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4468&filename=APTA-2217-08-RDS-2009-01-16.pdf
Description
APTA-2217-08-RDS-2009-01-16.pdf
Learn more about this trial
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
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