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Clinical trials for Selexipag

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    18 result(s) found for: Selexipag. Displaying page 1 of 1.
    EudraCT Number: 2020-000475-21 Sponsor Protocol Number: 67896049PUH3001 Start Date*: 2021-03-31
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants who Participated in a Previous Selexipag Study.
    Medical condition: Pulmonary Hypertension.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-004783-22 Sponsor Protocol Number: 67896049PAH4005 Start Date*: 2020-12-03
    Sponsor Name:ACTELION Pharmaceuticals Ltd.
    Full Title: A PRospective, Multicenter, Single-arm, Open label, Phase 4 Study of the Effects of Selexipag on RighT Ventricular RemOdeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic REsonan...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000865-34 Sponsor Protocol Number: AC-065C202 Start Date*: 2014-09-16
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon second...
    Medical condition: Raynaud's Phenomenon secondary to Systemic Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10047065 - Vascular disorders 10037912 Raynaud's phenomenon PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003495-53 Sponsor Protocol Number: NL59009.018.16 Start Date*: 2016-11-29
    Sponsor Name:Academic Medical Center - Cardiology
    Full Title: Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease
    Medical condition: Pulmonary arterial hypertension related to congenital heart disease.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004035-21 Sponsor Protocol Number: AC-065A309 Start Date*: 2017-05-23
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension swi...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002817-21 Sponsor Protocol Number: AC-065A310 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as ...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) PL (Trial now transitioned) SE (Trial now transitioned) DE (Ongoing) ES (Ongoing) HU (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) PT (Trial now transitioned) LT (Trial now transitioned) FI (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000145-39 Sponsor Protocol Number: AC-065A203 Start Date*: 2018-10-22
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full 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
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) PL (Completed) Outside EU/EEA BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000216-42 Sponsor Protocol Number: AC-065A404 Start Date*: 2017-07-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) SE (Completed) DE (Completed) AT (Completed) PT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004887-74 Sponsor Protocol Number: AC-065D301 Start Date*: 2019-08-14
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants with Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.
    Medical condition: sarcoidosis-associated pulmonary hypertension (SAPH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) DE (Completed) HU (Prematurely Ended) PL (Completed) ES (Ongoing) BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003438-28 Sponsor Protocol Number: AC-065A308 Start Date*: 2016-03-04
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-cont...
    Medical condition: Pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NO (Completed) FR (Completed) DK (Completed) AT (Completed) GB (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-014992-31 Sponsor Protocol Number: AC-065A303 Start Date*: 2010-02-22
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension
    Medical condition: The intended indication is Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) SE (Completed) DK (Completed) GB (GB - no longer in EU/EEA) IE (Completed) PL (Completed) AT (Completed) HU (Completed) DE (Completed) SK (Completed) CZ (Completed) GR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-006453-12 Sponsor Protocol Number: NS-304/-03 Start Date*: 2008-07-21
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension i...
    Medical condition: Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) FR (Completed) BE (Completed) GB (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002823-41 Sponsor Protocol Number: AC-065B302 Start Date*: 2019-06-03
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipa...
    Medical condition: Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) CZ (Prematurely Ended) BE (Completed) NL (Completed) HU (Completed) AT (Completed) BG (Completed) DK (Prematurely Ended) PT (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-014490-41 Sponsor Protocol Number: AC-065A302 Start Date*: 2010-02-22
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension
    Medical condition: The intended indication is Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    15.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DK (Completed) FR (Completed) ES (Completed) SE (Completed) CZ (Completed) GB (Completed) IE (Completed) HU (Completed) AT (Completed) SK (Completed) DE (Completed) GR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002297-11 Sponsor Protocol Number: NOPRODPAPUH3001 Start Date*: 2022-03-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
    Medical condition: Pulmonary Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) BG (Trial now transitioned) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002448-10 Sponsor Protocol Number: BIA-51058-201 Start Date*: 2018-10-31
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH)
    Medical condition: Pulmonary arterial hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) PT (Completed) ES (Ongoing) GB (Temporarily Halted) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003093-27 Sponsor Protocol Number: GB002-1101 Start Date*: 2019-08-16
    Sponsor Name:GB002, Inc.
    Full Title: A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB00...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-002788-80 Sponsor Protocol Number: Uni-Koeln-4243 Start Date*: 2020-09-09
    Sponsor Name:University of Cologne
    Full Title: An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH) (MPO-PAH)
    Medical condition: Group 1: Pulmonary arterial hypertension (PAH) Group 2: Postcapillary pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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