A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Condition(s) studied
Investigational drug(s) / intervention(s)
selexipag (Uptravi): Film-coated tablets for oral administration
Study 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.
Eligibility
Primary outcome measure(s)
- Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State of Selexipag and Its Metabolite ACT-333679 Combined (AUCτ, ss, Combined) — Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
AUCτ, ss, combined was defined as the area under the plasma concentration-time curve over one dosing interval at steady state. AUCτ,ss,combined was calculated as 1/38 AUCτ,ss,selexipag plus 37/38 AUCτ,ss,ACT-333679.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Children'S Hospital Cardiac Care Center University Of Colorado | Aurora | Colorado | |
| University of Iowa Hospital | Iowa City | Iowa | |
| Seattle Children's Hospital | Seattle | Washington | |
| 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 | |
| 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 Gyorgy Orszagos Kardiologiai Intezet, Felnott kardiologiai osztaly | 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 |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03492177 on ClinicalTrials.gov ↗ ← All trials in France