Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT00246935
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-01
• Primary Completion: 2007-01
• Study Completion: 2007-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Efficacy.

Trial Locations

Locations (1)

Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation; 🇯🇵 Osaka, Japan