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Clinical trials for A Phase 4, Open-

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   44334   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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    5,957 result(s) found for: A Phase 4, Open-. Displaying page 18 of 298.
    EudraCT Number: 2013-005348-28 Sponsor Protocol Number: ARD-3150-1201 Start Date*: 2014-05-06
    Sponsor Name:Aradigm Corporation
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subje...
    Medical condition: Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10057582 Lung infection pseudomonal PT
    18.0 100000004855 10006446 Bronchiectasis NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) IT (Completed) ES (Completed) LV (Completed) RO (Completed) IE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002496-17 Sponsor Protocol Number: 206207-008 Start Date*: 2006-03-08
    Sponsor Name:Allergan Limited
    Full Title: A Six-Month, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open-Label Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Seg...
    Medical condition: Macular Oedema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-000686-37 Sponsor Protocol Number: PR-20-5006-C Start Date*: 2013-09-11
    Sponsor Name:Tesaro, Inc.
    Full Title: A Phase 1/2a, Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients with Advanced Solid Tumors and Lymphomas
    Medical condition: Solid tumors or lymphomas that have failed standard therapies or for which no standard treatment option(s) exist.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10065147 Malignant solid tumor LLT
    19.0 100000004851 10025324 Lymphomas unspecified NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002222-20 Sponsor Protocol Number: 331-201-00080 Start Date*: 2018-02-23
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005270-47 Sponsor Protocol Number: 309363 Start Date*: 2007-04-23
    Sponsor Name:Schering AG
    Full Title: International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg...
    Medical condition: relapsing multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028245 Multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed) IE (Completed) FR (Completed) AT (Completed) SE (Completed) ES (Completed) DE (Completed) HU (Completed) LV (Completed) SI (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000120-33 Sponsor Protocol Number: C-550-01 Start Date*: 2018-11-19
    Sponsor Name:Agenus Inc.,
    Full Title: A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with AGEN2034 in Subjects with Metas...
    Medical condition: Phase 1 – Part A dose escalation in patients with locally advanced, recurrent and/or metastatic solid tumor for which no standard therapy exists or standard therapy has failed. Phase 2 - Part B adv...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10008236 Cervical cancer stage IV LLT
    21.1 100000004864 10008231 Cervical cancer recurrent LLT
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000037-14 Sponsor Protocol Number: NEOD001-301 Start Date*: 2021-09-01
    Sponsor Name:Prothena Biosciences Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with ...
    Medical condition: AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, a...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002860-59 Sponsor Protocol Number: ISEE2009 Start Date*: 2022-12-08
    Sponsor Name:IVERIC bio, Inc.
    Full Title: An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of avacincaptad pegol (Complement C5 Inhibitor) in Patients with Geographic Atrophy Who Previously Co...
    Medical condition: geographic atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10063947 Geographic atrophy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) LV (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-005583-27 Sponsor Protocol Number: KB 041 Start Date*: 2008-05-19
    Sponsor Name:KEDRION
    Full Title: A multi-center, randomized, prospective, controlled open-label Phase II/III study to assess the safety and sealing efficacy of Kedrion Fibrin Sealant in patients eligible for anatomical pulmonary r...
    Medical condition: Primary or secondry lung cancer, or other parenchymal disease for which pulmonary resection surgery is indicated 3. Patients eligible for anatomical or atypical pulmonary resection lobe resectio...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024741 Lung lobectomy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000171-18 Sponsor Protocol Number: 3066A2-214-WW Start Date*: 2005-05-12
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
    Full Title: A Multi-center, Open-label Extension Study of the Safety and Tolerability of Long-term Administration of Oral CCI-779 (Temsirolimus) in Subjects with Relapsing Multiple Sclerosis Who Completed Stud...
    Medical condition: Multiple Sclerosis (Relapsing-remitting MS and Secondary progressive MS with relapses)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004175-23 Sponsor Protocol Number: A9451165 Start Date*: 2015-04-07
    Sponsor Name:Pfizer Japan Inc
    Full Title: A 52 weeks, open-label, multicenter study evaluating the efficacy and safety of gabapentin as adjunctive therapy in pediatric subjects who have completed the 12 weeks treatment in study A9451162.
    Medical condition: Epilepsy with partial seizures (including secondarily generalized seizures)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001562-15 Sponsor Protocol Number: CAAA601A22301 Start Date*: 2019-11-15
    Sponsor Name:Advanced Accelerator Applications SA
    Full Title: This is a multicenter, stratified, randomized, open-label comparator-controlled, Phase III study in patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs, d...
    Medical condition: Patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077559 Gastroenteropancreatic neuroendocrine tumour disease PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077560 Gastroenteropancreatic neuroendocrine tumor disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Ongoing) NL (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005762-34 Sponsor Protocol Number: MGCDB001 Start Date*: 2021-07-15
    Sponsor Name:Medical University of Lublin
    Full Title: A phase 2 clinical trial assessing the efficacy and safety of adding cladribine for treatment modifying course of seropositive myasthenia gravis
    Medical condition: Myasthenia gravis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-000785-33 Sponsor Protocol Number: HST20-CL01 Start Date*: 2023-08-18
    Sponsor Name:HemoShear Therapeutics
    Full Title: A Phase 2 Open-label, Dose Escalation Study of HST5040 in Subjects with Propionic or Methylmalonic Acidemia Followed by a 6-Month, Randomized, Double-blind, Placebo-controlled, 2-Period Crossover S...
    Medical condition: Methylmalonic Acidemia (MMA) Propionic Acidemia (PA)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000744-13 Sponsor Protocol Number: C-935788-012 Start Date*: Information not available in EudraCT
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) FR (Completed) IT (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002854-11 Sponsor Protocol Number: OOC-ACM-302 Start Date*: 2016-04-18
    Sponsor Name:Chiasma, Inc.
    Full Title: A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPS...
    Medical condition: Acromegaly
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10000599 Acromegaly PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) RO (Completed) LT (Completed) DE (Completed) NL (Prematurely Ended) ES (Completed) AT (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002458-21 Sponsor Protocol Number: MK8259-012-00 Start Date*: 2012-07-23
    Sponsor Name:MERCK SHARP & DOHME B.V.
    Full Title: Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab
    Medical condition: Ankylosing Spondylitis (Bechterew disease)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10002557 Ankylosing spondylitis and other inflammatory spondylopathies LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000619-42 Sponsor Protocol Number: PI14/00638 Start Date*: 2015-05-05
    Sponsor Name:FIBICO
    Full Title: An open, Phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome
    Medical condition: Chronic kidney disease and metabolic syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002446-21 Sponsor Protocol Number: ARTROCELL Start Date*: 2020-04-20
    Sponsor Name:IBSAL (Instituto de Investigación Biomédica de Salamanca)
    Full Title: Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in ...
    Medical condition: Knee osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001229-34 Sponsor Protocol Number: ALN-TTRSC-003 Start Date*: 2014-08-01
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: A Phase 2, Open-label Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTRSC in Patients with Transthyretin (TTR) Cardiac Amyloidosis Who Have Previo...
    Medical condition: Transthyretin (TTR) Cardiac Amyloidosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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