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Clinical trials for Restricted randomization

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    94 result(s) found for: Restricted randomization. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2018-002678-34 Sponsor Protocol Number: AMLSG30-18 Start Date*: 2019-08-06
    Sponsor Name:University Hospital Ulm
    Full Title: Randomized Phase III Study of Standard Intensive Chemotherapy versus Intensive Chemotherapy with CPX-351 in Adult Patients with Newly Diagnosed AML and Intermediate- or Adverse Genetics - AMLSG 30-18
    Medical condition: Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML ac...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001700-42 Sponsor Protocol Number: APHP200410 Start Date*: 2020-05-06
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Efficacy of captopril nebulization in Covid-19 patients suffering of SARS-CoV-2 pneumonia. A randomized phase II study
    Medical condition: Patient ≥18 with SARS Cov 2 pneumonia requiring oxygen administration.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2015-001641-89 Sponsor Protocol Number: PM1183-C-003-14 Start Date*: 2016-06-28
    Sponsor Name:Pharma Mar S.A.
    Full Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as Treatment in Patients w...
    Medical condition: Small-Cell Lung Cancer (SCLC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) BE (Completed) ES (Completed) DE (Completed) GR (Completed) PT (Completed) CZ (Completed) NL (Completed) BG (Completed) GB (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002555-10 Sponsor Protocol Number: DS1062-A-U304 Start Date*: 2022-07-21
    Sponsor Name:Daiichi Sankyo, Inc.
    Full Title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cance...
    Medical condition: Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002513-36 Sponsor Protocol Number: ASP-1929-301 Start Date*: 2019-08-16
    Sponsor Name:Rakuten Aspyrian, Inc.
    Full Title: A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician’s Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck ...
    Medical condition: Locoregional, recurrent head and neck squamous cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GR (Completed) BE (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004131-24 Sponsor Protocol Number: 67896062CTP3001 Start Date*: 2020-05-29
    Sponsor Name:ACTELION Pharmaceuticals Ltd.
    Full Title: A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in ino...
    Medical condition: Chronic thromboembolic pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) ES (Prematurely Ended) AT (Completed) SK (Completed) LT (Completed) FR (Completed) IT (Prematurely Ended) PT (Prematurely Ended) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-002842-60 Sponsor Protocol Number: eNERGY Start Date*: 2017-09-14
    Sponsor Name:CHU Rennes
    Full Title: Randomised phase III study testing nivolumab and ipilimumab versus a carboplatin based doublet in first line treatment of PS 2 or elderly (more than 70 years old) patients with advanced non-small...
    Medical condition: Advanced non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020935 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002393-12 Sponsor Protocol Number: PRODIGE49 Start Date*: 2016-08-26
    Sponsor Name:Fédération Francophone de Cancérologie Digestive
    Full Title: Systemic oxaliplatin or in intra-arterial chemotherapy combined with LV5FU2 and targeted therapy in first-line treatment of metastatic colorectal cancer restricted to the liver
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002443-28 Sponsor Protocol Number: ACE-CL-311/D8221C00001 Start Date*: 2019-05-08
    Sponsor Name:Acerta Pharma B.V.
    Full Title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investiga...
    Medical condition: Previously untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10009310 CLL LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted) HU (Trial now transitioned) CZ (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001491-29 Sponsor Protocol Number: Prodige52–UCGI29 Start Date*: 2016-10-13
    Sponsor Name:UNICANCER
    Full Title: A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for high-risk stage III colon cancer in adjuvant setting
    Medical condition: High-risk stage III colon cancer in adjuvant setting
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009955 Colon cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-004748-36 Sponsor Protocol Number: PA-CL-03A Start Date*: 2008-10-30
    Sponsor Name:Vifor (International) Inc.
    Full Title: An open-label, randomized, active controlled multi center phase II dose finding study to evaluate the ability of PA21 to lower serum phosphate levels and the tolerability in patients with chronic k...
    Medical condition: Hyperphosphatemia in patients with chronic kidney disease on maintenance hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020712 Hyperphosphatemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-003655-66 Sponsor Protocol Number: I4T-MC-JVDC Start Date*: 2015-04-30
    Sponsor Name:Lilly S.A
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab plus Docetaxel versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial ...
    Medical condition: Locally advanced or unresectable or metastatic urothelial carcinoma who have had disease progression on or after one prior first-line platinum-based chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) DK (Completed) DE (Completed) NL (Completed) PL (Completed) GB (GB - no longer in EU/EEA) BE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004554-30 Sponsor Protocol Number: LOXO-BTK-20020 Start Date*: 2021-06-04
    Sponsor Name:Loxo Oncology Inc
    Full Title: A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/...
    Medical condition: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004169-33 Sponsor Protocol Number: P04705 Start Date*: 2007-10-16
    Sponsor Name:Schering-Plough Research Institute, a division of Schering Corporation
    Full Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (DISKUS®) Versus Mometasone Furoate/Formoterol Fumarate 200/1...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003553 Asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) SK (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001377-31 Sponsor Protocol Number: HZNP-DAX-203 Start Date*: 2022-12-09
    Sponsor Name:Horizon Therapeutics Ireland DAC
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    Medical condition: ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2008-003540-11 Sponsor Protocol Number: HO96GVHD Start Date*: 2010-02-24
    Sponsor Name:HOVON Foundation
    Full Title: Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phas...
    Medical condition: Graft versus Host Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10018799 GVHD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004128-42 Sponsor Protocol Number: E2609-G000-302 Start Date*: 2017-07-25
    Sponsor Name:Eisai Ltd.
    Full Title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease
    Medical condition: Early Alzheimer Disease including mild cognitive impairment (MCI) due to AD/Prodromal AD and the early stages of mild AD
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10012271 Dementia Alzheimer's type PT
    20.0 10029205 - Nervous system disorders 10001896 Alzheimer's disease LLT
    20.0 10029205 - Nervous system disorders 10074616 Prodromal Alzheimer's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) PL (Prematurely Ended) CZ (Completed) PT (Prematurely Ended) FI (Prematurely Ended) HU (Completed) FR (Completed) DK (Prematurely Ended) IT (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002533-11 Sponsor Protocol Number: AC-055-315 Start Date*: 2020-06-17
    Sponsor Name:ACTELION Pharmacteuticals Ltd.
    Full Title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Toler...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) CZ (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) NO (Completed) SK (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-001514-41 Sponsor Protocol Number: G040188 Start Date*: 2005-07-06
    Sponsor Name:The Cardiovascular Research Foundation
    Full Title: A dual arm factorial randomized trial in patients with ST segment elevation AMI to compare the results of using either anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibitio...
    Medical condition: The medical condition for this clinical trial is Acute Myocardial Infarction (AMI). AMI is defined as death or necrosis of myocardial cells. It is a diagnosis at the end of the spectrum of myocardi...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Prematurely Ended) ES (Completed) DE (Completed) GB (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001370-88 Sponsor Protocol Number: IBCSG 35-07/ BIG 1-07 Start Date*: 2007-11-06
    Sponsor Name:International Breast Cancer Study Group (IBCSG)
    Full Title: A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor...
    Medical condition: Postmenopausal women who are disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen receptor modulator(s) (SERM) and/or aromatase inhibitor(s) (AI) for endocri...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057654 Breast cancer female LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed) BE (Completed) HU (Completed) IT (Completed) DE (Completed) DK (Completed) GB (Completed) ES (Completed) SI (Completed) GR (Completed) AT (Completed) IE (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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