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

NCT02999906 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: TDE-PH-313
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH; Oral Treprostinil; dual therapy; 6 Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Distance (6MWD)

  Baseline to Week 28

Secondary Outcomes (4)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching placebo (sugar pill)

Drug: Placebo

Active

ACTIVE COMPARATOR

Oral treprostinil sustained release tablet

Drug: Oral Treprostinil

Interventions

Oral Treprostinil DRUG

Sustained release oral tablets for three times daily administration

Also known as: treprostinil diethanolamine

Active

Placebo DRUG

Placebo (sugar pill) for three times daily oral administration

Also known as: matching placebo (sugar pill)

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Nursing or pregnant
• 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.

Sponsors & Collaborators

• United Therapeutics: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil; Sugars

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 21, 2016
• Study Start: October 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share