Efficacy and safety of roflumilast in Japanese patients older than 40 Years with chronic obstructive pulmonary disease (APTA-2217-06)

Study identifier:APTA-2217-06

ClinicalTrials.gov identifier:NCT00242294

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A confirmatory study of APTA-2217 in patients with chronic obstructive pulmonary disease (A placebo-controlled double-blind comparative study)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2/3

Healthy volunteers

None

Study drug

Roflumilast

Sex

All

Actual Enrollment

570

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Nov 2004
Primary Completion Date: 01 Sept 2006
Study Completion Date: 01 Mar 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