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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

November 14, 2011
January 11, 2017
October 2011
November 2013   (Final data collection date for primary outcome measure)
  • 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).

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.
Complete list of historical versions of study NCT01477333 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
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 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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • 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
Experimental: UT-15C SR BID
Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated.
Interventions:
  • Drug: UT-15C SR
  • Drug: Tyvaso Inhalation Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2013
November 2013   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01477333
TDE-PH-203
No
Not Provided
Not Provided
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Study Chair: Cynthia Madden, MD, MPH Associate Director, Medical Development
United Therapeutics
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP