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Clinical trials for Biopterin

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   44335   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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    4 result(s) found for: Biopterin. Displaying page 1 of 1.
    EudraCT Number: 2005-003778-13 Sponsor Protocol Number: PKU-007 Start Date*: 2006-07-13
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Phenoptin in Subjects with Hyperphenylalaninemia Due to Primary BH4 Deficiency
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10034872 Phenylketonuria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012338-56 Sponsor Protocol Number: VAS203/II/1/03 Start Date*: 2009-07-10
    Sponsor Name:vasopharm GmbH
    Full Title: AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY
    Medical condition: Moderate and severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060690 Traumatic brain injury LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003368-29 Sponsor Protocol Number: VAS203/III/1/04 Start Date*: 2016-05-31
    Sponsor Name:vasopharm GmbH
    Full Title: EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY. A confirmatory, placebo-controlled, randomised, double blind, multi-centre study.
    Medical condition: Moderate and severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10060690 Traumatic brain injury LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-006141-16 Sponsor Protocol Number: OXBIO Start Date*: 2006-10-13
    Sponsor Name:University of Oxford
    Full Title: A Randomised, Placebo-Controlled Study of Two Doses of Oral 6R-BH4 on Vascular Function in Subjects with Coronary Artery Disease
    Medical condition: Coronary Artery Disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011078 Coronary artery disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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