Status:
COMPLETED
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
Brief Summary
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1333 Patients enrolled
Trial Details
Trial ID
NCT01266265
Start Date
December 1 2010
End Date
December 1 2014
Last Update
February 17 2016
Active Locations (88)
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1
Cardiovascular Associates, P.C.
Birmingham, Alabama, United States, 35213
2
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
University of South Alabama
Mobile, Alabama, United States, 36693
4
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States, 85013