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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01477333
First received: November 14, 2011
Last updated: January 11, 2017
Last verified: January 2017
  Purpose

The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments.

Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Change in Hemodynamic Parameters From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]

    Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

    Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).


  • Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]
    Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

  • Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]

    Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

    Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2).


  • Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]
    Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

  • Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]

    Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

    Cardiopulmonary hemodynamic measurements included cardiac index (CI).


  • Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24. [ Time Frame: Baseline and Week 24 ]

    Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.

    Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI).



Secondary Outcome Measures:
  • Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period. [ Time Frame: Baseline and Weeks 4, 12, and 24 ]
    The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit.

  • Time to Clinical Worsening Over the Treatment Period. [ Time Frame: Clinical worsening was assessed continuously from Baseline through each subject's last study visit ]
    Clinical worsening was assessed continuously from Baseline through each subject's last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin.

  • Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period. [ Time Frame: Baseline and Weeks 4, 8, 12, and 24 ]
    The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment).

  • N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period. [ Time Frame: Weeks 12 and 24 ]
    NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted.


Enrollment: 18
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C SR BID
Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated.
Drug: UT-15C SR
Initiated at 0.125 mg BID, titrated as clinically indicated.
Other Name: treprostinil diethanolamine, sustained release
Drug: Tyvaso Inhalation Solution
Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline
Other Name: Treprostinil

  Eligibility

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

Significant inclusion criteria includes:

  1. Subjects were between 18 to 75 years of age
  2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease, Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years)
  3. Had been receiving Tyvaso for at least 4 weeks (≥9 breaths, 4 times a day [QID]) and required additional therapy
  4. In addition to Tyvaso, subjects may have been 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 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, 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: Cynthia Madden, MD, MPH Associate Director, Medical Development
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01477333     History of Changes
Other Study ID Numbers: TDE-PH-203
Study First Received: November 14, 2011
Results First Received: August 1, 2016
Last Updated: January 11, 2017

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

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 21, 2017