Clinical Trial: Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When C

Brief Summary: A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Detailed Summary:
Sponsor: Actelion

Current Primary Outcome:

  • Number of Patients Reporting Treatment-emergent Adverse Events (AEs) [ Time Frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours ]
    Number of patients reporting at least one treatment-emergent AE/Serious AE
  • Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE [ Time Frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days ]
    Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
  • Number of Patients Reporting Treatment-emergent Serious AEs [ Time Frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours ]
    Number of patients reporting at least one treatment-emergent serious AEs
  • Systolic Blood Pressure - Iloprost PD-6 (Period 1) [ Time Frame: Day 1 ]
    Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
  • Systolic Blood Pressure - Iloprost PD-15 (Period 2) [ Time Frame: Day 28 ]
    Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
  • Systolic Blood Pressure - Iloprost PD-15 (Period 3) [ Time Frame: an average of approximately 268 days ]
    Systolic blood pressure was measured at the end of

    Original Primary Outcome: Treatment-emergent adverse events (AEs) [ Time Frame: From the first dose of investigational product to the last dose of investigational product ]

    Current Secondary Outcome:

    • Average Inhalation Time - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Inhalation Time - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Inhalation Time - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Change in Average Inhalation Time - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Days of Dosing - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Days of Dosing - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Days of Dosing - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Change in Average Number of Days of Dosing - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Daily Doses - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Daily Doses - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Average Number of Daily Doses - Iloprost PD-15 (Period 3) [ Time Frame: average of approximately 240 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Change in Average Number of Daily Doses - (Period 1 to Period 2) [ Time Frame: average approximately 56 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
    • Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2) [ Time Frame: average of approximately 28 days ]
      The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each tim

      Original Secondary Outcome:

      • Adverse events leading to study discontinuation [ Time Frame: From the first dose of investigational product to study discontinuation ]
      • Treatment-emergent serious adverse events [ Time Frame: From the first dose of investigational product up to 48 hours after investigational product discontinuation ]
      • Changes in vital signs [ Time Frame: Between baseline and Day 28 ]


      Information By: Actelion

      Dates:
      Date Received: July 24, 2008
      Date Started: July 2008
      Date Completion:
      Last Updated: March 27, 2013
      Last Verified: March 2013