Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

Completed

Conditions studied: Pulmonary Arterial Hypertension

In brief

A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

Key facts

Study ID

NCT01266265

Run by

United Therapeutics

People needed

1333

Starts

2010-12-01

Expected to finish

2014-12-01

Last updated by the study team

2016-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Arizona Pulmonary Specialists, LTD — Phoenix, Arizona, United States
• Berkeley Cardiovascular Medical Group — Berkeley, California, United States
• Cedars-Sinai Heart Institute — Beverly Hills, California, United States
• University California San Francisco — Fresno, California, United States
• University of Southern California — Los Angeles, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Paloma Medical Group — San Juan Capistrano, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Children's Hospital Denver — Denver, Colorado, United States
• Western States Clinical Research, Inc. — Wheat Ridge, Colorado, United States
• St. Francis Sleep Allergy & Lung — Clearwater, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Pulmonary and Critical Care Associates — Jacksonville, Florida, United States
• University of Florida College of Medicine Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Miami Center for Cardiovascular Disease — Miami, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Central Florida Pulmonary Group, P.A. — Orlando, Florida, United States
• Orlando Heart Center — Orlando, Florida, United States
• Cardiovascular Associates, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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