Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Phase 1

• Conditions: Pulmonary arterial hypertension; MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000216-42-AT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-09
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified