NCT02999906
Withdrawn
Phase 3
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 (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
ConditionsPulmonary Arterial Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Oral Treprostinil
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- United Therapeutics
- Primary Endpoint
- Change in 6-Minute Walk Distance (6MWD)
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Between 18 and 79 years of age, inclusive
- •PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired \> 1 year), or appetite suppressant / toxin use
- •Receiving dual therapy (ambrisentan and tadalafil)
- •Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH
Exclusion Criteria
- •Nursing or pregnant
- •PAH due to conditions other than noted in the above inclusion criteria
- •Received PAH-specific drug therapy for \>2 years
- •History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension
- •Participated in an investigational drug or device study within 90 days prior to signing consent.
Arms & Interventions
Active
Oral treprostinil sustained release tablet
Intervention: Oral Treprostinil
Placebo
Matching placebo (sugar pill)
Intervention: Placebo
Outcomes
Primary Outcomes
Change in 6-Minute Walk Distance (6MWD)
Time Frame: Baseline to Week 28
Secondary Outcomes
- Compare the effects of triple therapy versus dual therapy on the time to clinical worsening(Baseline to Week 28)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations From Baseline to Week 28(Baseline to week 28)
- Number of Participants with a Change From Baseline World Health Organization (WHO) Functional Classification at Week 28.(Baseline to week 28)
- Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 28.(Baseline to week 28)
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