Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease
Verified date | September 2016 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | October 2007 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation | Osaka |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Mitsubishi Tanabe Pharma Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) . | |||
Secondary | Efficacy. |
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