Ensayos clínicos

Inclusion Criteria:

- Symptomatic pulmonary arterial hypertension (PAH) in any PAH subtype

- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to or at
the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure
greater than (>) 20 millimeters of mercury (mm Hg), and b) Pulmonary artery wedge
pressure or left ventricular end diastolic pressure less than or equal to (<=) 15 mm
Hg, and c) Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units
(that is, >= 240 dynes seconds per centimeters penta [dyn?sec/cm^5])

- Participant satisfies either a or b: a) Newly initiating 1 or more PAH therapy(ies)
(as monotherapy or add-on therapy) at index date. These newly initiated PAH therapies
should not have been used within 3 months of the index date; b) Taking macitentan 10
milligrams (mg) therapy (as monotherapy or in combination) with no changes in PAH
therapy for within 3 months prior to the index date

- All mandated assessments must be performed and recorded at the baseline visit before
the initiation of the new PAH therapy at the index date or enrollment in the study.

- For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy
only: Participants initiating any endothelin receptor antagonist (ERA) or
phosphodiesterase-5 inhibitor therapies at index date or at therapy change must
provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give
consent for the optional PAH-SYMPACT substudy will not exclude a participant from
participation in the main study

Exclusion Criteria:

- Participants enrolled in any interventional clinical trial with an investigational
therapy in the 3-month period prior to index date

- Currently enrolled in an observational study sponsored or managed by a Janssen company

- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] <70%; and FEV1 <60% of predicted after
bronchodilator administration) in participants with a known or suspected history of
significant lung disease, as documented by a spirometry test performed within 1 year
prior to screening

- Presence of moderate or severe restrictive lung disease (for example, total lung
capacity or FVC <60 percent [%] of normal predicted value) in participants with a
known or suspected history of significant lung disease, as documented by a spirometry
test performed within 1 year prior to screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/27/22.  Questions regarding updates should be directed to the study team contact.