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Clinical trials for tadalafil and 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
  • 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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    8 result(s) found for: tadalafil and ambrisentan. Displaying page 1 of 1.
    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: 2012-002354-23 Sponsor Protocol Number: H6D-MC-LVHV Start Date*: Information not available in EudraCT
    Sponsor Name:Eli Lilly and Company
    Full Title: A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension
    Medical condition: 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: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) IT (Prematurely Ended) AT (Completed) NL (Completed) PL (Completed) ES (Completed) RO (Ongoing) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001873-24 Sponsor Protocol Number: H6D-MC-LVIG Start Date*: 2012-01-13
    Sponsor Name:Eli Lilly and Company
    Full Title: A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004786-25 Sponsor Protocol Number: AC-077A301 Start Date*: 2019-09-05
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of maciten...
    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: DE (Completed) PL (Completed) ES (Ongoing) BG (Completed) IT (Completed)
    Trial results: (No results available)
    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)
    EudraCT Number: 2010-018322-40 Sponsor Protocol Number: AC-066A301 Start Date*: 2010-05-20
    Sponsor Name:ACTELION Pharmaceuticals Ltd
    Full Title: A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) NL (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001189-40 Sponsor Protocol Number: APD811-303 Start Date*: 2023-04-05
    Sponsor Name:Arena Pharmaceuticals, Inc.
    Full Title: A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION
    Medical condition: Pulmonary arterial hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10077731 Pulmonary hypertension WHO functional class I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SE (Prematurely Ended) GB (GB - no longer in EU/EEA) CZ (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) HR (Completed) IT (Trial now transitioned) RO (Trial now transitioned)
    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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