Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Selexipag; Placebo
Intervention description: Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.; Matching film coated tablets
Intervention MeSH terms: Selexipag
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: daily life; physical activity; actigraphy; PAH-SYMPACT

Summary:

      The primary objective of this study is to evaluate the effect of selexipag on the physical
      activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using
      a wearable wrist device (actigraph). The actigraph will collect data on daily life physical
      activity in the patient's real environment. In addition, the PAH symptoms and their impacts
      will be assessed by using an electronic patient reported outcome measure in the patient's
      real environment. Patients will be assigned randomly to either selexipag or placebo.
    

Eligibility 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 pulmonary arterial hypertension (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.

          -  If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or
             soluble guanylate cyclase (sGC) stimulator, these treatments 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®.

        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 within 3 months
             prior to screening.

          -  Any hospitalization during the last 30 days prior to screening.

          -  Severe coronary heart disease or unstable angina.

          -  Documented severe hepatic impairment or severe renal insufficiency at screening.

          -  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.