Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female between 18 and 75 years old inclusive. - Women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation. - Symptomatic PAH belonging to one of the following subgroups only: . Idiopathic . Heritable . Drug or toxin induced . Associated with one of the following: connective tissue disease; HIV infection; corrected simple congenital heart disease. - With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization: . Mean pulmonary artery pressure (mPAP) = 25 mmHg . Pulmonary vascular resistance (PVR) = 240 dyn•sec/cm5 (or 3 Wood Units) . Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) = 15 mmHg. - Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization. - Possible treatment with a Phosphodiesterase-5 inhibitor or sGC stimulator must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization. - WHO functional class (FC) II or III at randomization. - 6-minute walk distance (6MWD) = 100 m at screening. - Ability to walk without a walking aid. - Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5 inhibitor or sGC stimulator). - Patients treated with prostacyclin, prostacyclin analog or selexipag at any time prior to Day 1. - Any hospitalization during the last 30 days prior to screening (Visit 1). - Severe coronary heart disease or unstable angina. - Documented severe hepatic impairment or severe renal insufficiency at screening (Visit 1). - Participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening. - Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of selexipag on daily life physical activity (DLPA) of patients with pulmonary arterial hypertension (PAH) as assessed by a wearable actigraphy device.;Secondary Objective: • To evaluate the effect of selexipag on PAH symptoms and their impacts in patients’ daily life. • To evaluate the effect of selexipag on exercise capacity, and disease severity in patients with PAH. • To evaluate the safety and tolerability of selexipag in patients with PAH.;Primary end point(s): - Change from baseline to Week 24 / EOT in actigraphy-assessed daily life physical activity (DLPA) as measured by: . Daily time spent (minutes) in non-sedentary activity (> 100 activity counts per minute) . Percentage of daily time spent in non-sedentary activity (> 100 activity counts per minute) . Total DLPA in counts/min . Sleep variables: Total sleep time (minutes); wake after sleep onset (minutes); number of awakenings, sleep efficiency (percentage) ;Timepoint(s) of evaluation of this end point: Up to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline to Week 24 / EOT for following PAH SYMPACT® domain scores: . Cardiovascular symptom domain score . Cardiopulmonary symptom domain score . Physical impact domain score . Cognitive/emotional impact domain score - Change from baseline to Week 24 / EOT for following variables: . WHO FC . 6MWD . Borg dyspnea index at 6MWT . N-terminal pro b-type natriuretic peptide (NT-proBNP);Timepoint(s) of evaluation of this end point: Up to Week 24 | — |
Countries
Austria, France, Germany, Ireland, Netherlands, Norway, Portugal, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactGlobal Medical Affairs
Actelion Pharmaceuticals Ltd
Outcome results
None listed