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Clinical trials for Drug utilization review

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   44343   clinical trials with a EudraCT protocol, of which   7372   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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    36 result(s) found for: Drug utilization review. Displaying page 2 of 2.
    « Previous 1  2 
    EudraCT Number: 2018-001393-16 Sponsor Protocol Number: SHP607-202 Start Date*: 2019-06-21
    Sponsor Name:Premacure AB
    Full Title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Co...
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Trial now transitioned) SE (Prematurely Ended) FR (Completed) DE (Trial now transitioned) PT (Trial now transitioned) ES (Temporarily Halted) FI (Trial now transitioned) NL (Trial now transitioned) PL (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-000441-38 Sponsor Protocol Number: CPCRA 065 Start Date*: 2005-04-26
    Sponsor Name:National Institute of Allergy and Infectious Diseases, National Institutes of Health
    Full Title: Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
    Medical condition: HIV infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Prematurely Ended) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004789-14 Sponsor Protocol Number: D1050308 Start Date*: 2012-07-04
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder
    Medical condition: bipolar disorder I
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) BG (Completed) PL (Completed) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001755-41 Sponsor Protocol Number: GV971-007 Start Date*: 2021-02-10
    Sponsor Name:Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
    Full Title: A Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy and safety of sodium oligomannate (GV-971) in treatment of mild to mode...
    Medical condition: mild to moderate Alzheimer’s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-005012-42 Sponsor Protocol Number: 747-302 Start Date*: 2016-01-05
    Sponsor Name:Intercept Pharmaceuticals Inc.
    Full Title: A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT S...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Prematurely Ended) AT (Prematurely Ended) BE (Completed) DK (Prematurely Ended) FI (Prematurely Ended) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) FR (Ongoing) DE (Completed) BG (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004742-28 Sponsor Protocol Number: C16029 Start Date*: 2017-10-26
    Sponsor Name:Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda
    Full Title: A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
    Medical condition: Relapsed and/or Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Completed) BE (Completed) ES (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004790-90 Sponsor Protocol Number: D1050307 Start Date*: 2012-09-26
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A 12-WEEK, MULTICENTER, OPEN-LABEL EXTENSION STUDY IN SUBJECTS WITH SCHIZOPHRENIA
    Medical condition: schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002567-17 Sponsor Protocol Number: 8951-CL-0301 Start Date*: 2018-07-13
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of IMAB362 Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-Po...
    Medical condition: Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001150 Adenocarcinoma gastric PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002455-29 Sponsor Protocol Number: 15-AVP-786-303 Start Date*: 2018-07-31
    Sponsor Name:Avanir Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatment of Agitation...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) PL (Completed) BG (Completed) CZ (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000798-26 Sponsor Protocol Number: 20-AVP-786-306 Start Date*: 2021-06-22
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q...
    Medical condition: Agitation in patients with dementia of the Alzheimer’s type
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) DK (Trial now transitioned) BG (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003951-23 Sponsor Protocol Number: AG-221-AML-005 Start Date*: 2016-07-08
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 P...
    Medical condition: Newly diagnosed acute myeloid leukemia (AML) habouring an isocitrate dehydrogenase 1 (IDH1) or an isocitrate dehydrogenase 2 (IDH2) mutation, respectively, who are not candidates to receive intensi...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Completed) ES (Ongoing) NL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-015504-25 Sponsor Protocol Number: GAO4753g Start Date*: 2010-06-04
    Sponsor Name:GENENTECH, Inc
    Full Title: An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximab-refractory, ...
    Medical condition: CD20+, indolent NHL
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029547 Non-Hodgkin's lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) AT (Completed) DE (Completed) FR (Completed) IT (Completed) GB (Completed) ES (Completed) SE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-000799-39 Sponsor Protocol Number: 20-AVP-786-307 Start Date*: 2021-02-05
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q...
    Medical condition: Agitation in patients with dementia of the Alzheimer’s type
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) SK (Trial now transitioned) NL (Ongoing) SI (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000903-26 Sponsor Protocol Number: GBT440-032 Start Date*: 2022-02-02
    Sponsor Name:Global Blood Therapeutics, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease (HOPE Kids 2)
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016947-20 Sponsor Protocol Number: SGN35-005 Start Date*: 2010-05-27
    Sponsor Name:Seattle Genetics, Inc.
    Full Title: A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of resid...
    Medical condition: Patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
    Disease: Version SOC Term Classification Code Term Level
    12.1 10020328 Hodgkin's lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) HU (Completed) ES (Completed) CZ (Completed) GB (Completed) BG (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007803-10 Sponsor Protocol Number: 3144A2-3005 Start Date*: 2009-08-26
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: A Randomized, Open-Label, Two-Arm Study of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer
    Medical condition: ErbB2 Positive Locally Recurrent or Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) DE (Completed) IT (Completed) GB (Completed) ES (Completed) BE (Completed) LV (Completed) PT (Completed) LT (Completed) FR (Completed) GR (Completed) DK (Completed) MT (Completed) BG (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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