Clinical Trial: Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
Brief Summary: Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome:
- Number of fully inhaled doses per day versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ]
- Number of fully inhaled doses in total versus the recommended number as a measure of compliance [ Time Frame: Up to 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 6 minute walking distance test (MWDT) value [ Time Frame: Up to 12 months ]
- Score on dyspnea Borg CR (category ratio) 10 scale [ Time Frame: Up to 12 months ]
- Patients' quality of life, assessed by validated questionnaire [ Time Frame: Up to 12 months ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: September 20, 2013
Date Started: December 15, 2013
Date Completion: August 31, 2017
Last Updated: May 2, 2017
Last Verified: May 2017