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

United Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Oral Treprostinil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02999906

TDE-PH-313

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between 18 and 79 years of age, inclusive
2. 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
3. Receiving dual therapy (ambrisentan and tadalafil)
4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion criteria

1. Nursing or pregnant
2. PAH due to conditions other than noted in the above inclusion criteria
3. Received PAH-specific drug therapy for >2 years
4. History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension
5. Participated in an investigational drug or device study within 90 days prior to signing consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo (sugar pill)

Treatment:

Drug: Placebo

Active

Active Comparator group

Description:

Oral treprostinil sustained release tablet

Treatment:

Drug: Oral Treprostinil