Clinical Trials

Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies

Location:

Jacksonville,  FL,  Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

Who is eligible to participate?

Inclusion Criteria:

- Clinical diagnosis of PAH, WHO GROUP I

- Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH

- Willing and able to provide written informed consent

Exclusion Criteria:

- Previous initiation and permanent discontinuation of Tyvaso

- Participation in an investigational clinical drug or device trial within 30 days of enrollment

- Current or past diagnosis of lung neoplasm

- Active gastrointestinal or pulmonary bleed at enrollment

- Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant

Last updated: 10/05/2012

NCT ID:

NCT01266265