drugset / Trial / NCT00246922

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).

NCT00246922

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 asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Timeline

Start
2004-12-01
Primary completion
2007-01-01
Completion
2007-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Roflumilast Small molecule Oral

Indications