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

StatusCompleted
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study title revisedv12
  2. Primary completion date: Jan 2007 to Jan 1, 2007
    • Study completion date: Oct 2007 to Oct 1, 2007
    • Start date: Dec 2004 to Dec 1, 2004
    v11
  3. Lead sponsor: Takeda to AstraZenecav10
  4. Study Identification, Study Statusv9
  5. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 2009 to Oct 2007
    • Eligibility criteria revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study site revisedv7
  2. Primary completion date: Jan 2007
    • Study completion date: Mar 2009
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study title expanded, about 1 wordv4
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
734 trials monitored
See 60 trials at risk
Asthma
960 trials monitored
See 37 trials at risk
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.
Trial Details
NCT Number NCT00246922
Lead Sponsor AstraZeneca
Collaborators: Tanabe Pharma Corporation
Conditions
(from sponsor)		 Bronchial Asthma
Related terms Asthma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov