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Clinical trials for Primary metabolites

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    374 result(s) found for: Primary metabolites. Displaying page 5 of 19.
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    EudraCT Number: 2016-004078-16 Sponsor Protocol Number: DOSCORT20092231 Start Date*: 2020-11-23
    Sponsor Name:Sahlgrenska University Hospital, Gothenburg
    Full Title: A dose-response study of markers of glucocorticoid action (DOSCORT)- A double-blind, randomized, two-period, two-dose, cross-over study in subjects with primary adrenal insufficiency
    Medical condition: Adrenal insufficiency e.g. Addison´s disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-004386-15 Sponsor Protocol Number: MBG308 Start Date*: Information not available in EudraCT
    Sponsor Name:GE Healthcare Limited and its affiliates
    Full Title: An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma
    Medical condition: Phaeochromocytoma and Neuroblastoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-004728-13 Sponsor Protocol Number: I3Y-MC-JPBL Start Date*: 2014-07-09
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without LY2835219, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced ...
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) DE (Completed) FI (Completed) GR (Trial now transitioned) RO (Ongoing) DK (Completed) PL (Trial now transitioned) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001425-10 Sponsor Protocol Number: 747-202 Start Date*: 2008-10-13
    Sponsor Name:Intercept Pharmaceuticals
    Full Title: A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) AT (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002218-36 Sponsor Protocol Number: I3Y-MC-JPCJ Start Date*: 2017-01-17
    Sponsor Name:Eli Lilly and Company
    Full Title: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients wi...
    Medical condition: Metastatic Pancreatic Ductal Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10033599 Pancreatic adenocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) BE (Completed) GB (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002996-91 Sponsor Protocol Number: CB8025-21629 Start Date*: 2017-02-21
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an in...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002935-14 Sponsor Protocol Number: EMPRA Start Date*: 2016-11-22
    Sponsor Name:Medical University of Vienna, Internal Medicine III, Clinical Div. of Nephrology and Dialysis
    Full Title: Effect of empagliflozin on the renin-angiotensin system in patients with chronic kidney disease with and without type 2 diabetes
    Medical condition: Chronic kidney disease with and without type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    20.0 100000004857 10076410 Chronic kidney disease stage 3 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002978-30 Sponsor Protocol Number: KG2104940 Start Date*: 2005-11-28
    Sponsor Name:GlaxoSmithKlin Research and Development Ltd
    Full Title: A double-blind, randomized, placebo-controlled, repeat dose study to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK189075 with GW869682 in subjects with type 2 diabe...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    7.1 10003601 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003670-40 Sponsor Protocol Number: PAN.1 Start Date*: 2018-04-05
    Sponsor Name:Beatrix Children's Hospital, University Medical Center Groningen
    Full Title: Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question.
    Medical condition: Pediatric Acute Respiratory Distress Syndrome necessitating mechanical ventilation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004033-15 Sponsor Protocol Number: B2C108562 Start Date*: 2006-09-29
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 and 400...
    Medical condition: Chronic Obstructive Pulmonary Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-002374-46 Sponsor Protocol Number: UC-0110/1807 Start Date*: 2018-11-09
    Sponsor Name:UNICANCER
    Full Title: A randomised phase II trial assessing REGorafenib combined with IRInotecan as second-line treatment in patients with metastatic gastro-oesophageal adenocarcinomas.
    Medical condition: Patients aged ≥18 years old with metastatic gastro-oesophageal adenocarcinomas after failure of a first-line fluoropyrimidine and platinum-based chemotherapies.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003100-13 Sponsor Protocol Number: KKSH-154 Start Date*: 2020-08-03
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention
    Medical condition: Nonvalvular Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-005006-62 Sponsor Protocol Number: ASZ-001 Start Date*: 2019-12-10
    Sponsor Name:Albert Schweitzer hospital
    Full Title: Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass
    Medical condition: Roux-en-Y gastric bypass
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10033762 Paracetamol LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-007740-10 Sponsor Protocol Number: TAM-01 Start Date*: 2008-01-30
    Sponsor Name:AZIENDA OSPEDALIERA OSPEDALI GALLIERA
    Full Title: Randomized placebo-controlled phase III trial of low-dose tamoxifen women whit IntraEphitelial Neoplasia(IEN)
    Medical condition: chemoprevention of breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006187 Breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004135-89 Sponsor Protocol Number: D516FC00001 Start Date*: 2022-04-07
    Sponsor Name:AstraZeneca AB
    Full Title: Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation positive Sta...
    Medical condition: Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del, L858R), following complete tumour resection.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029517 Non-small cell lung cancer stage I PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003723-29 Sponsor Protocol Number: JBT101-CF-002 Start Date*: 2018-05-11
    Sponsor Name:Corbus Pharmaceuticals, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
    Medical condition: Cystic Fibrosis (CF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed) SE (Completed) FR (Completed) PT (Completed) SK (Completed) AT (Completed) BE (Completed) ES (Completed) BG (Completed) NL (Completed) CZ (Completed) GR (Completed) PL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-001523-39 Sponsor Protocol Number: D1050300 Start Date*: 2013-11-08
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A PHASE 1 OPEN-LABEL, MULTICENTER, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF LURASIDONE IN SUBJECTS 6 TO 17 YEARS OLD WITH SCHIZOPHRENIA SPE...
    Medical condition: schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10001064 Acute schizophrenia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002969-19 Sponsor Protocol Number: REN001-101 Start Date*: 2019-01-29
    Sponsor Name:Reneo Pharma Ltd.
    Full Title: An open-label study to evaluate the safety and tolerability of 12 weeks treatment with oral REN001 in patients with primary mitochondrial myopathy (PMM), with an optional extension of treatment
    Medical condition: Primary mitochondrial myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002897-30 Sponsor Protocol Number: GS-US-334-0154 Start Date*: 2014-01-10
    Sponsor Name:Gilead Sciences Inc.
    Full Title: A Phase 2b Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 HCV-Infected Subjects with Renal Insufficiency
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    17.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-016775-30 Sponsor Protocol Number: NETU-08-18 Start Date*: 2011-02-24
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A phase III multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study of the efficacy and safety of oral netupitant administered in combination with palonosetron ...
    Medical condition: Nausea and vomiting in cancer patients receiving moderately emetogenic theraphy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054133 Prophylaxis of nausea and vomiting PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) BG (Completed) IT (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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