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Clinical trials for My Health Record

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    11 result(s) found for: My Health Record. Displaying page 1 of 1.
    EudraCT Number: 2011-001644-29 Sponsor Protocol Number: SAS115359 Start Date*: 2012-05-04
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) DE (Completed) ES (Completed) LT (Completed) SE (Completed) LV (Completed) HU (Completed) CZ (Completed) BE (Completed) NL (Completed) PL (Completed) IT (Completed) DK (Completed) SK (Completed) FI (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-005735-91 Sponsor Protocol Number: 178-CL-101 Start Date*: 2013-11-12
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabeg...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) NL (Completed) CZ (Completed) HU (Completed) LV (Completed) SE (Completed) IT (Completed) EE (Completed) FI (Completed) SK (Completed) SI (Completed) DK (Completed) ES (Completed) LT (Completed) PL (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-004087-19 Sponsor Protocol Number: ALN-AT3SC-009 Start Date*: 2017-08-25
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ATLAS-PPX trial: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in hemophilia A and B patients previously receiving factor or bypassing a...
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011913 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: ES (Prematurely Ended) IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-005736-29 Sponsor Protocol Number: 178-CL-102 Start Date*: 2014-07-08
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to S...
    Medical condition: Overactive Bladder
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004857 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) HU (Completed) IT (Completed) FI (Completed) GB (Completed) EE (Completed) SE (Completed) SK (Completed) CZ (Completed) LV (Completed) DK (Completed) SI (Completed) PL (Completed) ES (Completed) LT (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2022-000289-16 Sponsor Protocol Number: REGEN-016 Start Date*: 2023-04-11
    Sponsor Name:ProKidney
    Full Title: A PHASE 3 RANDOMIZED CONTROLLED STUDY OF REACT IN PARTICIPANTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (REGEN-016)
    Medical condition: TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
    Disease: Version SOC Term Classification Code Term Level
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) AT (Prematurely Ended) BE (Completed) PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001463-36 Sponsor Protocol Number: EFC14768 Start Date*: 2018-07-25
    Sponsor Name:Genzyme Corporation
    Full Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) DE (Completed) DK (Completed) NL (Not Authorised) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004011-28 Sponsor Protocol Number: A4250-012 Start Date*: 2021-01-26
    Sponsor Name:Albireo AB
    Full Title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) NL (Completed) BE (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001552-19 Sponsor Protocol Number: TOPMATEPY4067 Start Date*: 2014-12-16
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared with Levetiracetam as Monotherapy in Pediatric Subjects ...
    Medical condition: New-onset or recent-onset epilepsy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed) HU (Completed) BE (Completed) DE (Completed) GB (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001464-11 Sponsor Protocol Number: ALN-AT3SC-004 Start Date*: Information not available in EudraCT
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011913 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IE (Prematurely Ended) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001059-39 Sponsor Protocol Number: P 04103 Start Date*: 2005-11-10
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting with...
    Medical condition: Primary Hyperlipidermia
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10016205 Familial hyperlipidaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) SE (Completed) ES (Completed) BE (Completed) CZ (Completed) IT (Completed) DE (Completed) GB (Completed) AT (Completed) PT (Completed) SK (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015713-51 Sponsor Protocol Number: 205.452 Start Date*: 2010-06-09
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG, Medical Affairs Germany
    Full Title: A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FI (Completed) LV (Completed) HU (Completed) NO (Completed) LT (Completed) SK (Completed) SE (Completed) ES (Completed) NL (Completed) DK (Completed) PT (Completed) GR (Completed) AT (Completed) IT (Completed) IE (Completed) BG (Completed) GB (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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