Oral selexipag is commercially available in several countries for the treatment of a
particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH).
The aim of the present study is to investigate whether selexipag could be helpful to treat
patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary hypertension (PH) is a pathophysiological disorder that may involve multiple
clinical conditions and can complicate several cardiovascular and respiratory diseases.
Sarcoidosis is a multisystemic disorder that is characterized by non-caseating granulomas
which are present in multiple tissues, particularly in the lung and lymphatic system. Severe
untreated pulmonary hypertension (PH) carries a poor prognosis and is associated with higher
mortality in participants with interstitial lung diseases and sarcoidosis. While there is no
approved treatment for SAPH, PH-specific treatments are frequently used. Selexipag is a
selective, orally available and long-acting non-prostanoid agonist of the prostacyclin
receptor (prostacyclin [IP] receptor) for the treatment of patients with PAH. The rationale
for this study is based on the unmet medical need for new therapeutic options for patients
with SAPH and is supported by the established efficacy and safety of selexipag in the PAH
indication, the shared pathomechanism between SAPH and PAH, and the available data on the
efficacy and safety of PH-specific therapies in SAPH. This study consists of screening
period, main observation period and double blind extension period and safety follow-up
period. The duration of individual participation in the study will be different for each
individual participant (between approximately 15 months and up to approximately 3.5 years)
and will depend on the time of each participant's individual date of entering the study and
the total recruitment time. The efficacy assessments include right heart catheterization
(RHC), assessment of exercise capacity, dyspnea, pulmonary function tests, etc. Safety and
tolerability will be evaluated throughout the study and includes review of concomitant
medications and adverse events (AEs), clinical laboratory tests, 12-lead electrocardiogram
(ECG), vital signs, physical examination, and pregnancy testing.
Experimental: Selexipag 200 micro gram (μg)
Study intervention will be up-titrated to allow each participant to reach their individual maximum tolerated dose (iMTD), in the range of 200 μg to1600 μg (ie, 1 to 8 tablets) twice daily/once daily. Dosing frequency will be twice daily, except for participants with moderate hepatic impairment (Child-Pugh Class B) or who are concomitantly taking (a) moderate CYP2C8 inhibitor(s), who receive study intervention once daily. The dose will be up-titrated by the investigator/delegate in 200 μg twice daily/once daily increments at weekly intervals during scheduled TCs until reaching the iMTD. If the dose regimen is not well tolerated or symptoms cannot be fully managed with symptomatic treatment, the duration of the titration step can be prolonged to 2 weeks. If needed, the dose can be reduced by 200 μg twice daily/once daily.
Placebo Comparator: Placebo
The comparator will be administered similarly to the experimental intervention.
Drug: - Selexipag
Oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 (200 µg) to 8 (1600 µg) tablets at each administration
Drug: - Placebo
Oral tablets without active compound. Participants can receive 1 to 8 tablets at each administration.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Duke University Medical Center
Durham, North Carolina, 27710
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland, Ohio, 44195-0001
Medical University of South Carolina (MUSC) - College of Medicine (COM)
Charleston, South Carolina, 29425-8900
Universitaire Ziekenhuizen Leuven
Leuven, , 3000
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
Fortaleza, , 60840-285
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , 90035-074
Hospital das Clinicas de Porto Alegre
Porto Alegre, , 90035-903
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Sao Paulo, , 05403-000
London Health Sciences Centre
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Bobigny, , 93000
GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel
Bron Cedex, , 69677
Hôpital Kremlin Bicêtre
Le Kremlin Bicetre Cedex, , 94270
Marseille cedex 20, , 13915
CHU de Nancy - Hôpital de Brabois
Vandoeuvre les Nancy Cedex, , 54511
Evangelische Lungenklinik Berlin
Berlin, , 13125
Bonn, , 53105
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, , 01307
Heidelberg, , 69126
Luebeck, , 23538
Regensburg, , 93053
RBK Lungenzentrum Stuttgart am Robert-Bosch-Krankenhaus
Stuttgart, , 70839
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, , 97074
Ospedale S.Giuseppe, Gruppo MultiMedica
Milano, , 20123
Fondazione Maugeri Montescano
Pavia, , 27100
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, , 00165
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
Roma, , 00168
A.O.U. Città della Salute e della Scienza
Torino, , 10126
Amsterdam, , 1081 HV
Sint Antonius Ziekenhuis
Nieuwegein, , 3435 CM
Hosp. Clinic I Provincial de Barcelona
Barcelona, , 08036
Hosp. Univ. Marques de Valdecilla
Santander, , 39008
Royal Free Hospital
London, , NW3 2QG
Royal Brompton Hospital
London, , SW3 6NP