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
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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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...
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