Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2011 |
| End Date: | March 2013 |
| Contact: | Leigh Peterson, PhD |
| Email: | lpeterson@unither.com |
| Phone: | 919-425-8165 |
An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
The purpose of this multi-center, open-label, safety and tolerability study is to assess the
addition of UT-15C SR to patients currently receiving Tyvaso (treprostinil) inhalation
solution. The study will consist of a 24-week evaluation period followed by a long-term
safety follow up. Assessments will include: hemodynamics, 6MWT, Borg dyspnea score,
NT-proBNP, WHO functional class, and safety assessments.
Eligible patients will have a diagnosis of PAH, currently be receiving Tyvaso, and may be
receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a
stable dose for ≥ 30 days). At Baseline, subjects will receive the first dose of 0.125 mg
UT-15C SR.
Significant inclusion criteria includes:
1. Subjects will be between 18-75 years
2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease
(CVD), Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin
use, or repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years)
3. Have been receiving Tyvaso for at least 4 weeks (≥ 9 breaths, QID) and require
additional therapy
In addition to Tyvaso, subjects may be receiving other approved PAH specific oral
therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose).
We found this trial at
7
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
Click here to add this to my saved trials
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials