Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT03078907

Run by

Actelion

People needed

108

Starts

2017-11-08

Expected to finish

2020-02-10

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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®.

You may not qualify if…

• 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.

Where it is running

• LA Biomedical Research Institute — Torrance, California, United States
• Northside Hospital — Atlanta, Georgia, United States
• Kentuckiana Pulmonary Research Center — Louisville, Kentucky, United States
• Tufts Medical Center, Pulmonary/Critical Care & Sleep — Boston, Massachusetts, United States
• University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division — Omaha, Nebraska, United States
• NYU Winthrop Hospital — Mineola, New York, United States
• UNC Pulmonary Speciality Clinic — Chapel Hill, North Carolina, United States
• Duke University School of Medicine, Duke Pulmonary Vascular Disease center — Durham, North Carolina, United States
• University of Cincinnati, Heart, Lung and Vascular Institute — Cincinnati, Ohio, United States
• CCF- Akron General Medical Hospital — Cleveland, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• University of Pennsylvania, Pulmonary Vascular Disease Program — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center, Care Medicine — Nashville, Tennessee, United States
• Methodist Clinical Trials — San Antonio, Texas, United States
• University of Texas Health Science Center (San Antonio) — San Antonio, Texas, United States
• Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2 — Innsbruck, Austria
• Krankenhaus der Elisabethinen, Servicestelle Klinische Studien — Linz, Austria
• Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire — Le Kremlin-Bicêtre, France
• CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie — Lille, France
• Hospital Larrey CHU de Toulouse — Toulouse, France
• Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin — Cologne, Germany
• Universitätsklinikum Giessen — Giessen, Germany
• Universitätsklinikum Leipzig AöR, Abteilung Pneumologie — Leipzig, Germany
• Katholisches Klinikum Lünen/Werne GmbH, Haus E — Lünen, Germany
• Mater Misericordiae University Hospital — Dublin, Ireland

Full record on ClinicalTrials.gov

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