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Clinical trials for Hydroxylase

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
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    31 result(s) found for: Hydroxylase. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-002855-26 Sponsor Protocol Number: Droxidopa-301 Start Date*: 2008-10-01
    Sponsor Name:Chelsea Therapeutics Inc
    Full Title: A Multi-Centre, Double-Blind, Placebo-Controlled, Parallel-Group Induction-Design Study to assess the Clinical Effect of Droxidopa in Subjects with Primary Autonomic Failure, Dopamine Beta Hydroxyl...
    Medical condition: Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (Pharmacodynamic, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007105-36 Sponsor Protocol Number: Droxidopa-304 Start Date*: 2009-06-03
    Sponsor Name:Chelsea Therapeutics Inc.
    Full Title: A Multi-Centre, One Year Open-Label Study to Assess the Long-Term Safety of Droxidopa in Subjects with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and...
    Medical condition: Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase deficiency and Non-Diabetic Neuropathy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005701-22 Sponsor Protocol Number: Droxidopa-303 Start Date*: 2009-04-13
    Sponsor Name:Chelsea Therapeutics Inc
    Full Title: A MULTI-CENTER, OPEN-LABEL STUDY, WITH A TWO WEEK RANDOMIZED, PLACEBO-CONTROLLED, WITHDRAWAL PERIOD, TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF DROXIDOPA IN SUBJECTS WITH PRIMARY AUTONO...
    Medical condition: Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (PD, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-000648-15 Sponsor Protocol Number: BH4/III/05/001 Start Date*: 2006-06-08
    Sponsor Name:ORPHANETICS Pharma Entwicklungs- GmbH
    Full Title: A double-blind, placebo-controlled, multicentre study with an open-label extension to evaluate the efficacy and safety of tetrahydrobiopterin (BH4) in children and adolescents with hyperphenylalani...
    Medical condition: Hyperphenylalaninemia due to phenylalanine hydroxylase deficiency. Phenotypes: classic phenylketonuria (PKU), mild PKU (MPK) or mild hyperphenylalaninemia (HPA).
    Disease: Version SOC Term Classification Code Term Level
    81 10034873 LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005673-60 Sponsor Protocol Number: Droxidopa-302 Start Date*: 2009-04-22
    Sponsor Name:Chelsea Therapeutics Inc
    Full Title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP WITHDRAWAL-DESIGN STUDY TO ASSESS THE CLINICAL EFFECT OF DROXIDOPA IN SUBJECTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE ...
    Medical condition: Symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure (PD, MSA and PAF), DBH deficiency and Non-Diabetic Neuropathy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002205-69 Sponsor Protocol Number: Hepatooma Start Date*: 2009-08-24
    Sponsor Name:Organisation name was not entered
    Full Title: Investigation of Hepatic Tumors with Positron Emission Tomography Using [11C]-Metomidate and [11C]-Acetate Tracers
    Medical condition: This study is planned to determine and compare two new radiotracers (11C-labeled metomidate and acetate) in the detection of malignant and benign hepatic tumors. The detection of hepatocellular car...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001878-28 Sponsor Protocol Number: 307-201 Start Date*: 2019-12-17
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Safety and Efficacy of BMN 307, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Phenylalanine Hydroxylase in Subjects...
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10034872 Phenylketonuria PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-012978-12 Sponsor Protocol Number: ME026 Start Date*: Information not available in EudraCT
    Sponsor Name:Merck Serono, an affiliate of E. Merck AB
    Full Title: A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Norway to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® ...
    Medical condition: Hyperphenylalaninemia (HPA) in adults and children >=16 years of age with phenylketonuri (PKU) (classic or mild PKU, or mild hyperphenylalaninemia (HPA)).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10034872 Phenylketonuria LLT
    9.1 10034873 Phenylketonuria (PKU) LLT
    9.1 10034872 Phenylketonuria PT
    9.1 10034871 Phenylalaninemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001217-25 Sponsor Protocol Number: 2016-001217-25 Start Date*: 2016-09-07
    Sponsor Name:Uppsala University
    Full Title: Emotion, Serotonin and Premenstrual Dysphoric Disorder (EmSeP)
    Medical condition: Premenstrual Dysphoric Disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015768-33 Sponsor Protocol Number: EMR700773-003/BMN162-503 Start Date*: 2011-01-04
    Sponsor Name:BioMarin International Ltd.
    Full Title: A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patient...
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed) DE (Completed) AT (Completed) CZ (Completed) PT (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021343-41 Sponsor Protocol Number: ME040 Start Date*: 2014-03-21
    Sponsor Name:University Medical Center Groningen
    Full Title: Effect of sapropterin on variations of blood phenylalanine and tyrosine over 24 hours and from day to day in children with phenylketonuria
    Medical condition: Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder by a mutation in the gene for the enzyme phenylalanine hydroxylase (PAH), rendering it nonfunctional. Left untreated, the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000474-29 Sponsor Protocol Number: PTC923-MD-003-PKU Start Date*: Information not available in EudraCT
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A Phase 3 Study of PTC923 in Subjects with Phenylketonuria
    Medical condition: Metabolic Disorders - Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) PT (Completed) DK (Completed) NL (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-000497-28 Sponsor Protocol Number: PTC923-MD-004-PKU Start Date*: Information not available in EudraCT
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: Phase 3 Open-Label Study of PTC923 (Sepiapterin) in Phenylketonuria
    Medical condition: Metabolic Disorders - Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) PT (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024311-13 Sponsor Protocol Number: EMR700773-004 Start Date*: 2014-01-02
    Sponsor Name:Merck KGaA
    Full Title: A Multicenter, Double-Blind, Placebo Controlled, Randomized, 2-Arm Phase IIa Pilot Trial Assessing the Effect of Sapropterin on Cognitive Abilities in Young Adults with Phenylketonuria
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IT (Prematurely Ended) BE (Completed) ES (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015844-41 Sponsor Protocol Number: BMN162-502 Start Date*: 2013-07-25
    Sponsor Name:BioMarin International Ltd.
    Full Title: A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-Old Children with Phenylketonuria Treated with Sapropterin Dihydrochloride (Kuvan®) for 7 Years.
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Ongoing) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-004381-19 Sponsor Protocol Number: NBI-74788-CAH2006 Start Date*: 2021-06-07
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by O...
    Medical condition: Classic Congenital Adrenal Hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Ongoing) DE (Completed) FR (Ongoing) PL (Ongoing) BE (Ongoing) ES (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000839-10 Sponsor Protocol Number: PKU-008 Start Date*: 2006-08-09
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3b, Multicenter, Open-Label Extension Study of Phenoptin in Subjects with Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) IE (Completed) ES (Ongoing) GB (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003777-24 Sponsor Protocol Number: PKU-006 Start Date*: 2006-03-24
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Phenoptin 20 mg/kg/day to Increase Phenylalanine Tolerance in Phenylketonuric Child...
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-004512-23 Sponsor Protocol Number: PKU-003 Start Date*: 2005-05-22
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Phenoptin in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-004513-41 Sponsor Protocol Number: PKU-004 Start Date*: 2005-10-25
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    6.1 10034872
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) IT (Completed) DE (Completed)
    Trial results: View results
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