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Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

StatusCompleted
PhasePhase 2/3
Started
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Record History

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  1. Study title revisedv13
  2. Primary completion date: Sep 2006 to Sep 1, 2006
    • Study completion date: Jun 2007 to Jun 1, 2007
    • Start date: May 2004 to May 1, 2004
    v12
  3. Lead sponsor: Takeda to AstraZenecav11
  4. Re-verified, no change to tracked fieldsv10
  5. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 2009 to Jun 2007
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study site revisedv8
  2. Primary completion date: Sep 2006
    • Study completion date: Mar 2009
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study title expanded, about 1 wordv5
  5. 2 versions Re-verified since Apr 18, 2006, no change to tracked fieldsv3-v4
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
See 64 trials at risk
Asthma
956 trials monitored
See 36 trials at risk
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Trial Details
NCT Number NCT00242307
Lead Sponsor AstraZeneca
Collaborators: Tanabe Pharma Corporation
Conditions
(from sponsor)		 Bronchial Asthma
Related terms Asthma
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov