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Clinical trials for Sterols

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    10 result(s) found for: Sterols. Displaying page 1 of 1.
    EudraCT Number: 2021-001080-24 Sponsor Protocol Number: NL76906.068.21 Start Date*: 2021-04-08
    Sponsor Name:Maastricht University
    Full Title: The effect of plant stanol ester consumption on the vaccination response to a COVID-19 vaccine
    Medical condition: COVID-19 vaccination respons of people with BMI 27-35 kg/m2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004558-34 Sponsor Protocol Number: 20070360 Start Date*: 2008-12-17
    Sponsor Name:Amgen Inc
    Full Title: Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently ...
    Medical condition: Treatment of secondary hyperparathyroidism (SHPT) _______________________________________________ Tratamiento del hiperparatiroidismo secundario (HPTS)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020708 Hyperparathyroidism secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) DE (Completed) GB (Completed) BE (Completed) IT (Completed) IE (Completed) NO (Completed) GR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-000192-33 Sponsor Protocol Number: 20120360 Start Date*: 2013-07-12
    Sponsor Name:KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)
    Full Title: A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of A...
    Medical condition: Chronic Kidney Disease Secondary Hyperparathyroidism (SHPT)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004857 10064848 Chronic kidney disease LLT
    17.1 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Completed) IT (Completed) CZ (Completed) LV (Completed) SE (Completed) AT (Completed) BE (Completed) ES (Completed) EE (Completed) DE (Completed) GR (Completed) LT (Completed) DK (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-004643-53 Sponsor Protocol Number: 20050104 Start Date*: 2006-03-14
    Sponsor Name:Amgen Inc.
    Full Title: Bone Histomorphometry Assessment For Incident Dialysis Patients with Secondary Hyperparathyroidism of End Stage Renal Disease. Valoración ósea histomorfométrica en pacientes incidentes en diálisis...
    Medical condition: Secondary hyperparathyroidism (HPT) in subjects with CKD receiving dialysis. Hiperparatiroidismo (HPT) secundario en sujetos con IRC tratados con Diálisis.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) CZ (Completed) PT (Completed) IT (Completed) BE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002411-34 Sponsor Protocol Number: 20140315 Start Date*: 2019-01-28
    Sponsor Name:Amgen Inc.
    Full Title: Phase 3, Randomized, Open-label, Controlled, Multiple-Dose, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Etelcalcetide in Pediatric Subjects 28 days to < 18 Years of age With Sec...
    Medical condition: Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-004608-21 Sponsor Protocol Number: 20170724 Start Date*: 2019-07-30
    Sponsor Name:Amgen Inc.
    Full Title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of age With Secondary Hyperp...
    Medical condition: Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) GR (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) PT (Trial now transitioned) HU (Completed) FR (Completed) PL (Trial now transitioned) LT (Completed) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002806-31 Sponsor Protocol Number: 20120230(KAI-4169-007) Start Date*: 2013-02-12
    Sponsor Name:KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)
    Full Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease ...
    Medical condition: Secondary hyperparathyroidism in subjects with chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    14.1 10014698 - Endocrine disorders 10020706 Hyperparathyroidism NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) IT (Completed) ES (Completed) SE (Completed) HU (Completed) PL (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002805-23 Sponsor Protocol Number: 20120229(KAI-4169-006) Start Date*: 2013-01-22
    Sponsor Name:KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)
    Full Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease ...
    Medical condition: Secondary hyperparathyroidism in subjects with chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    16.1 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    16.1 10014698 - Endocrine disorders 10020706 Hyperparathyroidism NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) CZ (Completed) GB (Completed) IT (Completed) DE (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006271-70 Sponsor Protocol Number: P05522 Start Date*: 2009-03-03
    Sponsor Name:Schering-Plough Research Institute, A Division of Schering Corporation,
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Fa...
    Medical condition: -Primary Hypercholesterolemia (Heterozygous Familial [HeFH]) -Primary Hypercholesterolemia (Nonfamilial)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057079 Heterozygous familial hypercholesterolemia LLT
    9.1 10020604 Hypercholesterolemia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) IT (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023150-37 Sponsor Protocol Number: 20070208 Start Date*: 2011-07-21
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiv...
    Medical condition: Chronic Kidney Disease Secondary Hyperparathyroidism (SHPT)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    13.1 10014698 - Endocrine disorders 10020708 Hyperparathyroidism secondary PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Prematurely Ended) BE (Prematurely Ended) SK (Prematurely Ended) DE (Completed) Outside EU/EEA
    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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