Clinical Trial: Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

Brief Summary: This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. [ Time Frame: Month 3 Visit ]

Original Primary Outcome:

Current Secondary Outcome:

  • Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ]
  • Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ]
  • Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ]
  • The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ]
  • Other safety variable [ Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years) ]
    Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation
  • Other safety variables (optional assessment) [ Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years) ]
    Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses


Original Secondary Outcome:

Information By: Bayer

Dates:
Date Received: November 7, 2005
Date Started: April 2005
Date Completion:
Last Updated: January 30, 2015
Last Verified: January 2015