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Clinical trials for Prostanoids

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    22 result(s) found for: Prostanoids. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-001642-17 Sponsor Protocol Number: AMB116457 Start Date*: 2013-04-26
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Medical condition: Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed) DE (Completed) GB (Prematurely Ended) CZ (Prematurely Ended) NL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005223-90 Sponsor Protocol Number: PULSE-PAH-004 Start Date*: 2016-07-12
    Sponsor Name:Bellerophon Pulse Technologies LLC
    Full Title: A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS W...
    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 (Prematurely Ended) DE (Prematurely Ended) PT (Prematurely Ended) BE (Prematurely Ended) CZ (Prematurely Ended) NL (Prematurely Ended) AT (Prematurely Ended) HR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-005068-97 Sponsor Protocol Number: AC-052-414 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - bli...
    Medical condition: Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA: a.Idiopathic (IPAH) b.Familial (FPAH) c.Associated w...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064908 Associated with (APAH) LLT
    9.1 10064909 Idiopathic (IPAH) LLT
    9.1 10064910 Familial (FPAH) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) DK (Completed) GB (Completed) ES (Completed) PT (Completed) GR (Completed) BE (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2007-002440-14 Sponsor Protocol Number: AC-055-302 Start Date*: 2008-05-15
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomati...
    Medical condition: To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) NL (Completed) FR (Completed) FI (Completed) SE (Completed) AT (Completed) DK (Completed) SK (Completed) PT (Prematurely Ended) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-021572-29 Sponsor Protocol Number: AMB114588 Start Date*: 2010-11-23
    Sponsor Name:GlaxoSmithKline Research & Development, Ltd
    Full Title: An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064911 Pulmonary arterial hypertension LLT
    12.1 10065150 Associated with pulmonary arterial hypertension LLT
    12.1 10065151 Idiopathic pulmonary arterial hypertension LLT
    12.1 10065152 Familial pulmonary arterial hypertension LLT
    12.1 10064911 Pulmonary arterial hypertension PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) DE (Completed) NL (Ongoing) ES (Completed) HU (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003975-38 Sponsor Protocol Number: TERPAH-001 Start Date*: 2007-11-22
    Sponsor Name:Ergonex Pharma GmbH
    Full Title: Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective P...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036727 Primary pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Completed) CZ (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: 2013-004362-34 Sponsor Protocol Number: A1481324 Start Date*: 2015-08-26
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
    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: SE (Completed) AT (Completed) BE (Completed) DE (Completed) ES (Completed) CZ (Completed) RO (Completed) PL (Completed) GR (Completed) NL (Completed) PT (Completed) HR (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2005-006192-13 Sponsor Protocol Number: C200-006 Start Date*: 2006-06-22
    Sponsor Name:Actelion Pharmaceuticals US, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SI...
    Medical condition: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10037400 Pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Prematurely Ended) AT (Prematurely Ended) ES (Completed) PT (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000421-13 Sponsor Protocol Number: 1913 Start Date*: 2017-07-27
    Sponsor Name:Erasmus MC
    Full Title: Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial
    Medical condition: Congenital diaphragmatic hernia with pulmonary hypertension
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) NO (Prematurely Ended) AT (Prematurely Ended) SE (Ongoing) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000212-41 Sponsor Protocol Number: 206246 Start Date*: 2017-08-10
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension.
    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
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077739 Pulmonary arterial hypertension WHO functional class I LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077729 Pulmonary arterial hypertension WHO functional class III LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077740 Pulmonary arterial hypertension WHO functional class II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001675-37 Sponsor Protocol Number: Lis-Safe Start Date*: 2012-07-24
    Sponsor Name:Sinoxa Pharma GmbH
    Full Title: A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary ...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10036727 Primary pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004091-12 Sponsor Protocol Number: 1204-01 Start Date*: 2013-01-07
    Sponsor Name:Pluristem Ltd.
    Full Title: A Phase II, Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled, Parallel-Groups Study to Evaluate the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cel...
    Medical condition: Intermittent Claudication (IC); Fontaine class IIb; Rutherford category 2-3
    Disease: Version SOC Term Classification Code Term Level
    17.1 10047065 - Vascular disorders 10022562 Intermittent claudication PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002414-40 Sponsor Protocol Number: CXA-10-2302 Start Date*: 2019-12-17
    Sponsor Name:Complexa Inc.
    Full Title: A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects with Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-1...
    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
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004106-16 Sponsor Protocol Number: AC-052-375 Start Date*: Information not available in EudraCT
    Sponsor Name:Actelion pharmaceuticals Ltd
    Full Title: A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children wit...
    Medical condition: Pulmonary arterial hypertension (PAH) in children
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064908 Associated with (APAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064909 Idiopathic (IPAH) LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064910 Familial (FPAH) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) FR (Ongoing) PT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-003906-28 Sponsor Protocol Number: RC31/17/0447 Start Date*: 2020-02-24
    Sponsor Name:CHU de Toulouse
    Full Title: Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study
    Medical condition: Patients with systemic sclerosis presenting digital ulcer : - located beyond the proximal interphalangeal joint, on finger surface (included periungueal ulcers), - of ischemic origin according to...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022710-77 Sponsor Protocol Number: AC-055C301 Start Date*: 2011-06-16
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers a...
    Medical condition: Ischemic digital ulcers associated with systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) DK (Prematurely Ended) BG (Completed) FI (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-001646-18 Sponsor Protocol Number: AMB115811 Start Date*: 2013-04-25
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A randomised, multicentre, double-blind, placebo-controlled study of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Medical condition: Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) AT (Completed) DE (Completed) GB (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001910-13 Sponsor Protocol Number: AV-101-002 Start Date*: 2022-02-21
    Sponsor Name:Aerovate Therapeutics, Inc.
    Full Title: IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hy...
    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
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077729 Pulmonary arterial hypertension WHO functional class III LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077730 Pulmonary arterial hypertension WHO functional class IV LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077740 Pulmonary arterial hypertension WHO functional class II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022969-95 Sponsor Protocol Number: AC-055C302 Start Date*: 2011-12-21
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers a...
    Medical condition: Ischemic digital ulcers associated with systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10042953 Systemic sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) IE (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) NL (Completed) PT (Prematurely Ended) PL (Prematurely Ended) GR (Prematurely Ended)
    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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