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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02999906
• Date of registration: 19/12/2016
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
• Scientific 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 (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
• Date of first enrolment: October 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02999906
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Oral Treprostinil

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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

Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 28. [Time Frame: Baseline to 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]

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations From Baseline to Week 28 [Time Frame: Baseline to week 28]

Secondary ID(s)

TDE-PH-313

Source(s) of Monetary Support

Please refer to primary and secondary sponsors