Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 11-009137
NCT ID: NCT01266265
Sponsor Protocol Number: RIN-PH-403
About this study
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso® (treprostinil) Inhalation Solution versus other FDA approved therapies.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Charles Burger, M.D.
Closed for enrollment
Publications are currently not available