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Clinical trials for Ambrisentan

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
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    • 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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    29 result(s) found for: Ambrisentan. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-001193-28 Sponsor Protocol Number: AMB-320/321-E Start Date*: 2005-11-08
    Sponsor Name:Myogen, Inc
    Full Title: ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321"
    Medical condition: Pulmonary Arterial Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001139-22 Sponsor Protocol Number: POPH Start Date*: 2011-06-29
    Sponsor Name:Medizinische Universität Graz, Klin. Abteilung für Gastroenterologie und Hepatologie
    Full Title: AMBRISENTAN FOR TREATMENT OF PORTOPULMONARY HYPERTENSION (POPH): A PILOT STUDY
    Medical condition: Portopulmonary Hypertension (PoPH) and Hepatopulmonary Syndrome HPS are present in a considerable number of patients with compensated cirrhosis. Treatment of PoPH with ambrisentan is well tolerated...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10067281 Portopulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005104-20 Sponsor Protocol Number: N-003-CRD008 Start Date*: 2022-09-10
    Sponsor Name:Noorik Biopharmaceuticals AG
    Full Title: A randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ambrisentan in patients with severe COVID-19
    Medical condition: Treatment for respiratory complications of COVID-19 disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) CZ (Prematurely Ended) HR (Completed)
    Trial results: (No results available)
    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: 2005-000812-29 Sponsor Protocol Number: AMB 320 Start Date*: 2005-09-21
    Sponsor Name:Myogen, Inc.
    Full Title: Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    7.0 10037400 low
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) AT (Completed) BE (Completed) IT (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001564-31 Sponsor Protocol Number: AMB 222 Start Date*: 2005-10-07
    Sponsor Name:Myogen Inc.
    Full Title: A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    7.0 10037400 low
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001882-28 Sponsor Protocol Number: 2014-05ED Start Date*: 2014-10-13
    Sponsor Name:Thoraxklinik-Heidelberg gGmbH
    Full Title: Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH)
    Medical condition: Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2010-019547-19 Sponsor Protocol Number: AMB112529 Start Date*: 2010-07-16
    Sponsor Name:GlaxoSmithKline Research & Development, Ltd
    Full Title: A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in ...
    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) NL (Completed) HU (Completed) DE (Completed) ES (Completed) FR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001699-12 Sponsor Protocol Number: 205019 Start Date*: 2019-08-27
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambr...
    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, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011150-17 Sponsor Protocol Number: AMB112565 Start Date*: 2010-08-26
    Sponsor Name:GlaxoSmithKline R&D Ltd
    Full Title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary arterial hypotension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Completed) BE (Completed) SE (Completed) GB (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-002088-25 Sponsor Protocol Number: N-003-CRD003 Start Date*: 2019-01-11
    Sponsor Name:Noorik Biopharmaceuticals AG
    Full Title: A Phase II, Single-arm, Open-Label Study to Characterise the Effect on Portal Pressure, the Effect on Renal Function and the Pharmacokinetic Profile of N-003 in Patients with Decompensated Cirrhosis
    Medical condition: decompensated liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10064704 Decompensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-004405-34 Sponsor Protocol Number: GS-US-231-0101 Start Date*: 2010-09-13
    Sponsor Name:Gilead Sciences Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmon...
    Medical condition: Idiopathic pulmonary fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021240 Idiopathic pulmonary fibrosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) IE (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) BE (Completed) ES (Prematurely Ended) NL (Completed) FR (Completed) GB (Prematurely Ended) IT (Prematurely Ended)
    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: 2016-004806-32 Sponsor Protocol Number: RAMSES Start Date*: 2019-03-02
    Sponsor Name:ITALIAN PULMONARY HYPERTENSION NETWORK, IPHNET
    Full Title: Right ventriculAr reverse reModeling and hemodynamic improvement after add-on combination therapy (ambriSentan/PDE-5i) in PAH patientS (RAMSES)
    Medical condition: patients with pulmonary arterial hypertention
    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: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002229-27 Sponsor Protocol Number: TACTIC-E Start Date*: 2020-06-09
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Experimental drugs and mechanisms
    Medical condition: SARS-Cov-2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-011169-98 Sponsor Protocol Number: GS-US-300-0128 Start Date*: 2009-11-03
    Sponsor Name:Gilead Sciences, Inc
    Full Title: ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibr...
    Medical condition: Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10021240 Idiopathic pulmonary fibrosis LLT
    12.0 10037400 Pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010703-80 Sponsor Protocol Number: AC-063A301 Start Date*: 2009-06-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary ...
    Medical condition: Indication: Symptomatic Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001528-16 Sponsor Protocol Number: INS1009-202 Start Date*: 2022-05-30
    Sponsor Name:Insmed Incorporated
    Full Title: A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to valuate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in participants with Pu...
    Medical condition: Participants with 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, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned) AT (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned)
    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)
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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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