drugset / Trial / NCT00246935

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

NCT00246935

Phase 3 Completed 150 enrolled AstraZeneca Tanabe Pharma Corporation · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-05
Primary completion
2007-01
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Roflumilast Small molecule Oral