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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
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study title revised

    Show what changed: Study title
    [...] e Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).

    Study Identification, Study Statusv12

  2. Minor

    Primary completion date: Jan 2007 to Jan 1, 2007

    Completion date: Oct 2007 to Oct 1, 2007; Start date: Dec 2004 to Dec 1, 2004

    Study Status, Referencesv11

  3. Notable

    Lead sponsor: Takeda to AstraZeneca

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, Referencesv10

  4. Minor

    Study Identification, Study Status

    v9

  5. Minor

    Trial status: Active, Not Recruiting to Completed

    Study completion date changed from estimate of Mar 2009 to Oct 2007; Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] both 18 weeks and 24 weeks measurements during APTA-2217-05. Patients with poorly controlled asthma between informed con [...]

    Study Status, Eligibilityv8

Show 6 earlier versions

  1. Minor

    Study site revised

    Show what changed: Study sites
    ALTANA Pharma inNycomed Japan and TANABEMitsubishi SEIYAKUTanabe Co.,Pharma LTD.Corporation

    Study Status, Contacts/Locationsv7

  2. Minor

    Primary completion date: Jan 2007

    Completion date: Mar 2009

    Study Status, Sponsor/Collaborators, Contacts/Locationsv6

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v5

  4. Minor

    Study title expanded, about 1 word

    Show what changed: Study title
    Long-Term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

    Study Identification, Study Statusv4

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv3

  6. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v2

  1. Minor

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
727 trials monitored
See 63 trials at risk
Asthma
927 trials monitored
See 32 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 Bronchial Asthma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov