Clinical Trial: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambr

Brief Summary: This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.

Detailed Summary:
Sponsor: United Therapeutics

Current Primary Outcome: Change in 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline to Week 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare the effects of triple therapy versus dual therapy on the time to clinical worsening [ Time Frame: Baseline to Week 28 ]

    clinical worsening is defined by 1 of the following:

    • Death (all causes)
    • Hospitalization due to worsening PAH
    • Initiation of long-term parenteral therapy
    • Disease progression
    • Unsatisfactory long-term clinical response
  • Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations From Baseline to Week 28 [ Time Frame: Baseline to week 28 ]
    The level of this biomarker of the (NT-proBNP) serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 28.
  • Number of Participants with a Change From Baseline World Health Organization (WHO) Functional Classification at Week 28. [ Time Frame: Baseline to week 28 ]
    The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
  • Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 28. [ Time Frame: Baseline to week 28 ]
    The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 025; high scores indicate more symptoms), Activity (Score 030; low score indicates good functioning) and Quality of Life (025; high scores indicate poor QoL). The sum of these scores equates to the Total score (080). In the CAMPHOR scores, lower scores indicate improvements.


Original Secondary Outcome: Same as current

Information By: United Therapeutics

Dates:
Date Received: December 19, 2016
Date Started: April 2017
Date Completion: June 2022
Last Updated: February 15, 2017
Last Verified: December 2016