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Active, not recruitingNCT03492177Updated Sep 25, 2026Results posted

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

A Phase 2 interventional study of selexipag (Uptravi) in Pulmonary Arterial Hypertension, sponsored by Actelion. Active, not recruiting at 34 sites in 16 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Actelion · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
2 Years to 17 Years
Sex
All
01

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.

Read the detailed description

The selection of the starting dose for pediatric participants is based on the PK extrapolation from adults, taking into account the children body weight category, in order to lead to an exposure similar to that in adult PAH participants at a starting dose of 200 micrograms (mcg). As in adults, selexipag will be up-titrated to the individual maximum tolerated dose (iMTD) during the first 12 weeks. Approximately 60 participants will be enrolled in 3 different age cohorts to obtain at least 45 participants with evaluable PK profiles: Cohort 1: >= 12 to \< 18 years of age, Cohort 2: >= 6 to \< 12 years of age, Cohort 3: >= 2 to \< 6 years of age. In each age cohort the starting dose will depend on the body weight. Enrollment will start with both Cohort 1 and Cohort 2. After completion of PK assessments in at least 15 participants from Cohort 1 at Week 12, a first interim analysis will be conducted to establish the dose-exposure relationship using a population PK model. The PK data from any participants in Cohort 2 who have completed their PK assessments at this time will be included in this first interim analysis. Results of this model-based analysis will be used to confirm or adjust the selexipag doses initially selected. Enrollment of Cohort 3 (children >= 2 to \< 6 years of age) will start once the appropriate doses have been confirmed in a second interim analysis of PK data from Cohorts 1 and 2, and if there is no safety concern based on review by an Independent Data Monitoring Committee (IDMC).

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Pediatric
03

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Signed and dated informed consent by the parent(s) or Legally authorized representative(s) AND assent from developmentally capable children
  • Males or females between greater than or equal to (>=) 2 and less than (\<) 18 years of age with weight >= 9 kilograms (kg)
  • Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's enrollment

  • PAH with one of the following etiologies:

    • idiopathic (iPAH),
    • heritable (hPAH),
    • associated with congenital heart disease (CHD): PAH with co-incidental CHD; post-operative PAH (persisting/ recurring/ developing >= 6 months after repair of CHD)
    • Drug or toxin-induced
    • PAH associated with HIV
    • PAH associated with connective tissue disease
  • Word Health Organization functional class (WHO FC) II to III
  • Participants treated with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor provided that the treatment dose(s) has been stable for at least 3 months prior to enrollment, or participants who are not candidates for these therapies
  • Females of childbearing potential must have a negative pregnancy test at Screening and at Enrollment, and must agree to undertake monthly pregnancy tests, and to use a reliable method of contraception (if sexually active) from screening up to study drug discontinuation plus 30 days (EOS)

Key Exclusion Criteria:

  • Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease (PVOD) and/or pulmonary capillary hemangiomatosis
  • Participants with PAH associated with Eisenmenger syndrome
  • Participants with moderate to large left-to-right shunts
  • Participants with cyanotic congenital cardiac lesions such as transposition of the great arteries, truncus arteriosus, univentricular heart or pulmonary atresia with ventricular septal defect, as well as Participants with Fontan-palliation
  • Participants with pulmonary hypertension due to lung disease
  • Previous treatment with Uptravi (selexipag) within 2 weeks prior to enrollment
  • Participants having received prostacyclin (epoprostenol) or prostacyclin analogs (that is, treprostinil, iloprost, beraprost) within 2 months prior to enrollment or are scheduled to receive any of these compounds during the trial
  • Treatment with another investigational drug within 4 weeks prior to enrollment
  • History, or current suspicion of intussusception or ileus or gastrointestinal obstruction as per investigator's judgment
  • Uncontrolled thyroid disease as per investigator judgment
  • Hemoglobin or hematocrit \< 75 percentage (%) of the lower limit of normal range
  • Known severe or moderate hepatic impairment
  • Clinical signs of hypotension that in the investigator's judgment would preclude initiation of a PAH-specific therapy
  • Participants with severe renal insufficiency
  • Known hypersensitivity to the investigational treatment or to any of the excipients of the drug formulations
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    open label selexipag

    The first dose of selexipag (Uptravi) will be administered in the evening of Day 1 and will be based on the body weight. Thereafter selexipag will be administered twice daily (morning and evening). Selexipag will be up-titrated during the first 12 weeks, with weekly increments equal to the starting dose until the participants reach their individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline weight category is achieved (which will be 8-fold of the corresponding starting dose). Up-titration is followed by a stable maintenance treatment period from Week 12 to Week 16, at the maximum tolerated dose. Thereafter, participants will be treated with selexipag as long as the treatment is beneficial to the participants, as per investigator's decision.

    Drug: selexipag (Uptravi)

Interventions

  • Drugselexipag (Uptravi)

    Film-coated tablets for oral administration

    Also known as: ACT-293987, JNJ-67896049

05

What researchers measure

Primary outcomes

  1. 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)

    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.

    Time frame: 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)

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve Over a Dose Interval of Selexipag at Steady State (AUCτ,ss)

    Time frame: 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)

  2. Area Under the Plasma Concentration-Time Curve Over a Dose Interval of ACT-333679 at Steady State (AUCτ,ss)

    Time frame: 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)

  3. Maximum Observed Plasma Concentration of Selexipag at Steady State (Cmax,ss)

    Time frame: 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)

  4. Maximum Observed Plasma Concentration of ACT-333679 at Steady State (Cmax,ss)

    Time frame: 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)

  5. Time to Reach the Maximum Observed Plasma Concentration of Selexipag at Steady State (Tmax,ss)

    Time frame: 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)

  6. Time to Reach the Maximum Observed Plasma Concentration of ACT-333679 at Steady State (Tmax,ss)

    Time frame: 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)

  7. Trough Concentration of Selexipag at Steady State (Ctrough,ss)

    Time frame: 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)

  8. Trough Concentration of ACT-333679 at Steady State (Ctrough,ss)

    Time frame: 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)

  9. Number of Participants With Treatment-emergent Adverse Events (TEAEs) (End of Treatment [EOT] + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  10. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  11. Number of Participants With Adverse Events (AEs) Leading to Permanent Discontinuation of Study Drug

    Time frame: Up to 7 years

  12. Number of Participants With Treatment-emergent Deaths (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  13. Number of Participants With Treatment-emergent Marked Laboratory Abnormalities (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  14. Change From Baseline in Hematology Parameters (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  15. Change From Baseline in Chemistry Parameters (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  16. Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities (EOT + 3 Days)

    Time frame: EOT+3 days (Up to Week 17)

  17. Change From Baseline in Thyroid Stimulating Hormone (TSH) up to EOT + 3 Days

    Time frame: EOT+3 days (Up to Week 17)

  18. Change From Baseline in Blood Pressure

    Time frame: Up to 7 years

  19. Change From Baseline in Heart Rate

    Time frame: Up to 7 years

  20. Change From Baseline Over Time in Height up to EOT+3 Days

    Time frame: EOT+3 days (Up to Week 17)

  21. Change From Baseline Over Time in Body Mass Index (BMI) up to EOT + 3 Days

    Time frame: EOT+ 3 days (Up to Week 17)

  22. Change From Baseline in Sexual Maturation (Tanner Stage) up to End of Treatment (EOT + 3 Days)

    Time frame: EOT+ 3 days (Up to Week 17)

06

Results

Posted Apr 19, 2023

Participant flow

Participant flow — Overall Study
MilestoneCohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)
Started222120
Completed000
Not completed222120
Withdrew: Adverse event100
Withdrew: Death303
Withdrew: Lack of efficacy120
Withdrew: Other100
Withdrew: Ongoing161917

Outcome measures

PrimaryArea Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State of Selexipag and Its Metabolite ACT-333679 Combined (AUCτ, ss, Combined)

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.

Time frame:
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)
Reported as:
Geometric mean · nanograms*hour per milliliter
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)
nanograms*hour per milliliterCohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)
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)21.56 (17.32 to 26.84)20.40 (16.83 to 24.73)18.57 (15.16 to 22.74)
SecondaryArea Under the Plasma Concentration-time Curve Over a Dose Interval of Selexipag at Steady State (AUCτ,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryArea Under the Plasma Concentration-Time Curve Over a Dose Interval of ACT-333679 at Steady State (AUCτ,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryMaximum Observed Plasma Concentration of Selexipag at Steady State (Cmax,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryMaximum Observed Plasma Concentration of ACT-333679 at Steady State (Cmax,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryTime to Reach the Maximum Observed Plasma Concentration of Selexipag at Steady State (Tmax,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryTime to Reach the Maximum Observed Plasma Concentration of ACT-333679 at Steady State (Tmax,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryTrough Concentration of Selexipag at Steady State (Ctrough,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryTrough Concentration of ACT-333679 at Steady State (Ctrough,ss)
Time frame:
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)

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs) (End of Treatment [EOT] + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Serious Adverse Events (TESAEs) (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryNumber of Participants With Adverse Events (AEs) Leading to Permanent Discontinuation of Study Drug
Time frame:
Up to 7 years

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Deaths (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Marked Laboratory Abnormalities (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline in Hematology Parameters (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline in Chemistry Parameters (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities (EOT + 3 Days)
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline in Thyroid Stimulating Hormone (TSH) up to EOT + 3 Days
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline in Blood Pressure
Time frame:
Up to 7 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Heart Rate
Time frame:
Up to 7 years

Results for this outcome have not been posted.

SecondaryChange From Baseline Over Time in Height up to EOT+3 Days
Time frame:
EOT+3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline Over Time in Body Mass Index (BMI) up to EOT + 3 Days
Time frame:
EOT+ 3 days (Up to Week 17)

Results for this outcome have not been posted.

SecondaryChange From Baseline in Sexual Maturation (Tanner Stage) up to End of Treatment (EOT + 3 Days)
Time frame:
EOT+ 3 days (Up to Week 17)

Results for this outcome have not been posted.

Adverse events

Collected over Up to 3 years 8 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)3/22 (13.6%)12/22 (54.5%)21/22 (95.5%)
Cohort 2 (>=6 to <12 Years)0/21 (0%)4/21 (19%)20/21 (95.2%)
Cohort 3 (>=2 to <6 Years)3/20 (15%)6/20 (30%)17/20 (85%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventCohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)
Covid-19Infections and infestations4/221/210/20
PneumoniaInfections and infestations3/221/211/20
Cardiac ArrestCardiac disorders0/220/212/20
SyncopeNervous system disorders1/220/212/20
Pulmonary Hypertensive CrisisRespiratory, thoracic and mediastinal disorders2/220/211/20
GastritisGastrointestinal disorders0/220/211/20
DeathGeneral disorders0/220/211/20
BronchitisInfections and infestations1/220/211/20
Pneumonia AspirationInfections and infestations0/220/211/20
Urinary Tract InfectionInfections and infestations0/220/211/20
Most frequent other events
Showing 10 of 158
Most frequent other events
EventCohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)
HeadacheNervous system disorders11/2211/211/20
DiarrhoeaGastrointestinal disorders10/225/214/20
VomitingGastrointestinal disorders8/229/217/20
NauseaGastrointestinal disorders9/226/212/20
Abdominal PainGastrointestinal disorders6/224/212/20
PyrexiaGeneral disorders3/225/214/20
EpistaxisRespiratory, thoracic and mediastinal disorders4/225/211/20
FlushingVascular disorders5/222/210/20
FatigueGeneral disorders1/224/211/20
DizzinessNervous system disorders2/224/212/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)Total
Mean14.2 ± 1.798.5 ± 1.363.8 ± 1.289 ± 4.53
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)Total
Female15111036
Male7101027
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)Total
Hispanic or Latino1001
Not Hispanic or Latino18191956
Unknown or Not Reported3216
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)Total
Asian36716
White16121139
Unknown or Not Reported3216
Other0112
Region of Enrollment
Region of Enrollment(Participants)Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years)Cohort 2 (>=6 to <12 Years)Cohort 3 (>=2 to <6 Years)Total
BELARUS4239
BELGIUM0011
CHINA0178
FRANCE3115
GERMANY0101
HUNGARY1225
ISRAEL0123
MALAYSIA3407
RUSSIAN FEDERATION7029
TAIWAN0101
UKRAINE1405
UNITED KINGDOM0112
UNITED STATES1203
Serbia2114
07

Study locations

34 sites
  • Children'S Hospital Cardiac Care Center University Of Colorado
    Aurora, Colorado 80045, United States
  • University of Iowa Hospital
    Iowa City, Iowa 52242, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • State Institution Republican Scientific And Practical Center For Pediatric Surgery
    Minsk, 220013, Belarus
  • Health Institution 4Th City Children'S Clinical Hospital
    Minsk, 220118, Belarus
  • UZ Gent
    Ghent, 9000, Belgium
  • Centre Hospitalier Sainte Justine
    Montreal, Quebec H3T 1C4, Canada
  • Beijing Anzhen Hospital
    Beijing, 100029, China
  • Shanghai Childrens Medical Center
    Shanghai, 200127, China
  • CHU Arnaud de Villeneuve
    Montpellier, 34295, France
  • Hôpital Necker - Enfants Malades
    Paris, 75015, France
  • Chu Hopital Des Enfants
    Toulouse, 31059, France
  • Universitätsklinikum Freiburg Zentrum
    Freiburg im Breisgau, 70106, Germany
  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Felnott kardiologiai osztaly
    Budapest, 1096, Hungary
  • Schneider Children's Medical Center
    Petach Tikvah, Israel
  • Sheba Medical Center
    Ramat Gan, 52621, Israel
  • Sarawak Heart Center
    Kota Samarahan, 94300, Malaysia
  • Institut Jantung Negara (National Heart Institute)
    Kuala Lumpur, 50400, Malaysia
  • Wojewodzki Szpital Specjalistyczny We Wroclawiu
    Wroclaw, 51 124, Poland
  • Kazan State Medical University
    Kazan', 420059, Russia
  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems
    Kemerovo, 650002, Russia
  • Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies
    Moscow, 125412, Russia
  • Saint Petersburg State Pediatric Medical University
    Saint Petersburg, 194100, Russia
  • Almazov National Medical Research Center Of The Ministry Of Health Of The Russian Federation
    Saint Petersburg, 197341, Russia
  • Samara Regional Clinical Cardiological Dispensary
    Samara, 443070, Russia
  • Univerzitetska Dečja Klinika
    Belgrade, 11000, Serbia
  • Institut Za Zdravstvenu Zastitu Majke I Deteta Srbije Dr Vukan Cupic
    Belgrade, 11070, Serbia
  • National Cheng Kung University Hospital
    Tainan, 704, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Municipal Enterprise Of The Dnipropetrovsk Regional Council
    Dnipro, 49070, Ukraine
  • State Institution Of The Ministry Of Health Of Ukraine
    Kiev, 04050, Ukraine
  • Lviv Regional Clinical Hospital
    Lviv, 79010, Ukraine
  • Municipal Institution Of The Zaporizhzhya Regional Council
    Zaporizhzhya, 69063, Ukraine
  • Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
08

References and documents

Publications

  • Beghetti M, Axelsen LN, Borissoff JI, Farhan M, Grill S, Leng S, Russu A, Lesage C, Remenova T, Hsu Schmitz SF, Moledina S. A Prospective, Multicenter, Open-Label, Single-Arm Phase 2 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Selexipag in Children With Pulmonary Arterial Hypertension. Chest. 2026 May;169(5):1330-1344. doi: 10.1016/j.chest.2025.12.013. Epub 2025 Dec 20. PubMed 41429287 ↗

Study documents

  • Study protocol · Sep 30, 2021
  • Statistical analysis plan · May 2, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03492177
Lead sponsor
Actelion
Responsible party
Sponsor
First posted
Apr 10, 2018
Start date
Jul 23, 2018
Primary completion
Mar 28, 2022
Completion
Dec 31, 2026 (estimated)
Results posted
Apr 19, 2023
Last update
Sep 25, 2026

Study contacts

Catherine Boisson
study director · Actelion

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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