The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003438-28-DE

Enrollment

238

Registered

2016-01-19

Start date

2016-03-04

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH) MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Other descriptive name: SEL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent prior to any study-mandated procedure. - Initial PAH diagnosis =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Any PAH-specific drug therapy at any time.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve subjects with pulmonary arterial hypertension (PAH).;Secondary Objective: To compare an initial triple oral regimen (macitentan, tadalafil, selexipag) with an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve subjects with PAH, with respect to cardio-pulmonary hemodynamics (other than PVR), exercise capacity, disease severity, morbidity/mortality, safety, and tolerability.;Primary end point(s): Pulmonary vascular resistance;Timepoint(s) of evaluation of this end point: Baseline to Week 26	—

Measure

Time frame

Main Objective: To compare the effect on pulmonary vascular resistance (PVR) of an initial triple oral regimen (macitentan, tadalafil, selexipag) versus an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve subjects with pulmonary arterial hypertension (PAH).;Secondary Objective: To compare an initial triple oral regimen (macitentan, tadalafil, selexipag) with an initial dual oral regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve subjects with PAH, with respect to cardio-pulmonary hemodynamics (other than PVR), exercise capacity, disease severity, morbidity/mortality, safety, and tolerability.;Primary end point(s): Pulmonary vascular resistance;Timepoint(s) of evaluation of this end point: Baseline to Week 26

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Secondary

Measure	Time frame
Secondary end point(s): N-terminal pro B-type natriuretic peptide (NT-proBNP), 6-minute walk distance, WHO Functional Class, cardiac hemodynamics as assessed by right heart catheterization, time from randomization to the first disease progression event;Timepoint(s) of evaluation of this end point: Baseline to Week 26. For time to the first disease progression event, baseline to 26 weeks after last patient enrolled.	—

Measure

Time frame

Secondary end point(s): N-terminal pro B-type natriuretic peptide (NT-proBNP), 6-minute walk distance, WHO Functional Class, cardiac hemodynamics as assessed by right heart catheterization, time from randomization to the first disease progression event;Timepoint(s) of evaluation of this end point: Baseline to Week 26. For time to the first disease progression event, baseline to 26 weeks after last patient enrolled.

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Countries

Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactGlobal Medical Affairs

Actelion Pharmaceuticals Ltd

lperchen@its.jnj.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026