N/A
N=1,333
Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01266265 ↗Enrolled (actual)
1,333
Serious AEs
14.2%
Results posted
Feb 2016
Primary outcome: Primary: Prevalence of Respiratory Tract-Related Adverse Events of Interest — 52; 51; 16; 14 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- inhaled prostacyclin (Drug); prostacyclin (Drug); subcutaneous and intravenous prostacyclin (Drug); oral ERA (Drug); oral PDE5 inhibitors (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- United Therapeutics
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Respiratory Tract-Related Adverse Events of Interest |
52; 51; 16; 14; 17; 10 | — |
Summary
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01266265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.