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Clinical trials for Regional differentiation

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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    14 result(s) found for: Regional differentiation. Displaying page 1 of 1.
    EudraCT Number: 2015-003869-28 Sponsor Protocol Number: 9785-CL-0335 Start Date*: 2016-08-04
    Sponsor Name:Astellas Pharma Global Development, Inc (APGD)
    Full Title: ARCHES: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients ...
    Medical condition: Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing) BE (Completed) ES (Restarted) DK (Completed) FI (Completed) SE (Completed) DE (Completed) SK (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002932-18 Sponsor Protocol Number: 42756493-BLC3001 Start Date*: 2018-02-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
    Medical condition: Advanced Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) HU (Completed) ES (Ongoing) AT (Completed) FR (Trial now transitioned) DE (Ongoing) NL (Ongoing) PT (Completed) GR (Completed) PL (Completed) IT (Completed) DK (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003743-10 Sponsor Protocol Number: 2016-779 Start Date*: 2017-02-06
    Sponsor Name:Herlev og Gentofte Hospital
    Full Title: Effects of SGLT-2 Inhibitor on Myocardial Perfusion, Function and Metabolism in Type 2 DM Patients at high cardiovascular risk: The SIMPle Randomized Clinical Trial
    Medical condition: Type 2 diabetes and cardiovascular risk
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-001310-42 Sponsor Protocol Number: BL.13 Start Date*: 2019-10-15
    Sponsor Name:Canadian Cancer Trials Group (CCTG)
    Full Title: A randomized phase II trial assessing trimodality therapy with or without adjuvant Durvalumab (MEDI4736) to treat patients with muscle-invasive bladder cáncer
    Medical condition: Muscle-invasive bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066753 Bladder transitional cell carcinoma stage II PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066754 Bladder transitional cell carcinoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-001974-76 Sponsor Protocol Number: MK-3475-630 Start Date*: 2019-01-16
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Adv...
    Medical condition: Resectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041823 Squamous cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) HU (Trial now transitioned) ES (Ongoing) GR (Trial now transitioned) IE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004276-21 Sponsor Protocol Number: I3Y-MC-JPCM Start Date*: 2019-01-02
    Sponsor Name:Eli Lilly and Company
    Full Title: A Phase 2/3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
    Medical condition: Metastatic Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Trial now transitioned) DE (Restarted) GB (Completed) NL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000248-23 Sponsor Protocol Number: C3441052 Start Date*: 2021-10-22
    Sponsor Name:Pfizer Inc.
    Full Title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
    Medical condition: Metastatic Castration-sensitive Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) SK (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) BG (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003497-48 Sponsor Protocol Number: EMPATHY Start Date*: 2021-11-29
    Sponsor Name:Medical University of Warsaw
    Full Title: Empagliflozin and dapagliflozin in patients hospitalized for acute decompensated heart failure (EMPATHY) – a phase III trial
    Medical condition: acute decompensated heart failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10010684 Congestive heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-003229-91 Sponsor Protocol Number: POL6326-POL-006 Start Date*: 2013-06-27
    Sponsor Name:Polyphor AG
    Full Title: CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI) A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Multi-centre Study of POL6326, a CXCR4 A...
    Medical condition: Acute Myocardial Infarction
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004849 10064345 ST segment elevation myocardial infarction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) HU (Completed) PL (Completed) CZ (Completed) NO (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005079-10 Sponsor Protocol Number: TOK-200-15 Start Date*: 2015-07-14
    Sponsor Name:Tokai Pharmaceuticals Inc
    Full Title: ARMOR3-SV: A Phase 3, Randomized, Open-Label, Multi-Center, Controlled Study of Galeterone Compared with Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA with Metastatic Cast...
    Medical condition: Androgen receptor (AR) splice variant-7 (ARV7), metastatic (M1) castration resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10007453 Carcinoma of the prostate metastatic LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005276-14 Sponsor Protocol Number: RGCH004 Start Date*: 2016-06-03
    Sponsor Name:Sykehuset Østfold HF
    Full Title: Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial.
    Medical condition: Immune thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004851 10021245 Idiopathic thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) DK (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000423-12 Sponsor Protocol Number: CP506-001 Start Date*: 2022-12-13
    Sponsor Name:Maastricht University
    Full Title: A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic ...
    Medical condition: Tumour Agnostic treatment. ● Module differentiation: – Module 1 - monotherapy – solid tumour patients with cancer types that are enriched for HRD/FAD defects – Module 2 – combination with Carboplat...
    Disease: Version SOC Term Classification Code Term Level
    24.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084788 HRD positive advanced ovarian cancer LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033604 Pancreatic cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067821 Head and neck cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002036-32 Sponsor Protocol Number: C3441006(MDV3800-06) Start Date*: 2016-12-05
    Sponsor Name:Pfizer Inc.
    Full Title: TALAPRO 1: A PHASE 2, OPEN LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE BASED CHEMOTHE...
    Medical condition: Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) NL (Completed) ES (Ongoing) FR (Completed) BE (Completed) GB (Completed) AT (Completed) DK (Prematurely Ended) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020821-41 Sponsor Protocol Number: MDV3100-03 Start Date*: 2011-02-10
    Sponsor Name:Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
    Full Title: PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer W...
    Medical condition: Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) NL (Completed) ES (Completed) SE (Completed) AT (Completed) FI (Completed) DK (Completed) SK (Completed) IT (Completed) LT (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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