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ACTIVE NOT RECRUITING
NCT03492177
PHASE2

A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension

Sponsor: Actelion

View on ClinicalTrials.gov

Summary

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

Official title: A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2018-07-23

Completion Date

2026-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

selexipag (Uptravi)

Film-coated tablets for oral administration

Locations (34)

Children'S Hospital Cardiac Care Center University Of Colorado

Aurora, Colorado, United States

University of Iowa Hospital

Iowa City, Iowa, United States

Seattle Children's Hospital

Seattle, Washington, United States

State Institution Republican Scientific And Practical Center For Pediatric Surgery

Minsk, Belarus

Health Institution 4Th City Children'S Clinical Hospital

Minsk, Belarus

UZ Gent

Ghent, Belgium

Centre Hospitalier Sainte Justine

Montreal, Quebec, Canada

Beijing Anzhen Hospital

Beijing, China

Shanghai Childrens Medical Center

Shanghai, China

CHU Arnaud de Villeneuve

Montpellier, France

Hôpital Necker - Enfants Malades

Paris, France

Chu Hopital Des Enfants

Toulouse, France

Universitätsklinikum Freiburg Zentrum

Freiburg im Breisgau, Germany

Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

Budapest, Hungary

Schneider Children's Medical Center

Petach Tikvah, Israel

Sheba Medical Center

Ramat Gan, Israel

Sarawak Heart Center

Kota Samarahan, Malaysia

Institut Jantung Negara (National Heart Institute)

Kuala Lumpur, Malaysia

Wojewodzki Szpital Specjalistyczny We Wroclawiu

Wroclaw, Poland

Kazan State Medical University

Kazan', Russia

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Kemerovo, Russia

Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies

Moscow, Russia

Saint Petersburg State Pediatric Medical University

Saint Petersburg, Russia

Almazov National Medical Research Center Of The Ministry Of Health Of The Russian Federation

Saint Petersburg, Russia

Samara Regional Clinical Cardiological Dispensary

Samara, Russia

Univerzitetska Dečja Klinika

Belgrade, Serbia

Institut Za Zdravstvenu Zastitu Majke I Deteta Srbije Dr Vukan Cupic

Belgrade, Serbia

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Municipal Enterprise Of The Dnipropetrovsk Regional Council

Dnipro, Ukraine

State Institution Of The Ministry Of Health Of Ukraine

Kiev, Ukraine

Lviv Regional Clinical Hospital

Lviv, Ukraine

Municipal Institution Of The Zaporizhzhya Regional Council

Zaporizhzhya, Ukraine

Great Ormond Street Hospital

London, United Kingdom