Efficacy and safety of roflumilast in Japanese patients with bronchial asthma (20 to 70 y) (APTA-2217-05)

Study identifier:APTA-2217-05

ClinicalTrials.gov identifier:NCT00242307

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A confirmatory study of APTA-2217 in adult patients with bronchial asthma (A placebo-controlled double-blind comparative study)

Medical condition

Bronchial Asthma

Phase

Phase 2/3

Healthy volunteers

None

Study drug

Roflumilast

Sex

All

Actual Enrollment

450

Study type

Interventional

Age

20 Years - 70 Years

Date

Study Start Date: 01 May 2004
Primary Completion Date: 01 Sept 2006
Study Completion Date: 01 Jun 2007

Study design

Allocation: Randomized
Endpoint Classification: -
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