Long-term study of Safety and efficacy of Roflumilast in Japanese Patients Older Than 40 Years with Chronic Obstructive Pulmonary Disease (APTA-2217-08)

Study identifier:APTA-2217-08

ClinicalTrials.gov identifier:NCT00246935

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A long-term study of APTA-2217 in patients with chronic obstructive pulmonary disease

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

No

Study drug

Roflumilast

Sex

All

Actual Enrollment

150

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 May 2005
Primary Completion Date: 01 Jan 2007
Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

TANABE SEIYAKU Co., LTD.

Inclusion and exclusion criteria