- Trials with a EudraCT protocol (31)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (1)
31 result(s) found for: Hydroxylase.
Displaying page 1 of 2.
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). | |||||||||||||
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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 | |||||||||||||
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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)). | ||||||||||||||||||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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) | |||||||||||||
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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) | |||||||||||||
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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) | |||||||||||||
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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) | |||||||||||||
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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) | |||||||||||||
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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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