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Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by United Therapeutics.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: November 14, 2011
Last updated: February 5, 2013
Last verified: February 2013

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.

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: UT-15C SR
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability of the addition of UT-15C SR to Tyvaso [ Time Frame: ≥ 24 weeks ]
    This study consists of a 24-week evaluation period followed by a long term safety follow-up for provision of UT-15C SR until FDA approval or the study is otherwise terminated.

Secondary Outcome Measures:
  • Change in hemodynamic parameters [ Time Frame: 24 weeks ]
  • Change in exercise capacity as measured by the 6- minute walk test (6MWT) [ Time Frame: 24 weeks ]
  • Time to clinical worsening [ Time Frame: 24 weeks ]
  • World Health Organization (WHO) functional class [ Time Frame: 24 weeks ]
  • N-terminal pro-Brain Natriuretic Peptide (NTproBNP) [ Time Frame: 24 weeks ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: UT-15C SR
    Initiated at 0.125 mg BID, titrated as needed.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01477333

United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Allegheny General Hospital
Pittsburg, Pennsylvania, United States, 15212
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
United Therapeutics
Study Chair: Cindy Madden, MD, MPH Senior Clinical Research Physician
  More Information

Responsible Party: United Therapeutics Identifier: NCT01477333     History of Changes
Other Study ID Numbers: TDE-PH-203 
Study First Received: November 14, 2011
Last Updated: February 5, 2013

Keywords provided by United Therapeutics:

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents processed this record on February 28, 2017