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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01477333
First received: November 14, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Change in exercise capacity as measured by the 6- minute walk test (6MWT) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to clinical worsening [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • World Health Organization (WHO) functional class [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • N-terminal pro-Brain Natriuretic Peptide (NTproBNP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477333

Locations
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
Investigators
Study Chair: Cindy Madden, MD, MPH Senior Clinical Research Physician
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01477333     History of Changes
Other Study ID Numbers: TDE-PH-203
Study First Received: November 14, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Tyvaso
UT-15C SR
PAH

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013