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Clinical trials for .IMi

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    50 result(s) found for: .IMi. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2015-000066-62 Sponsor Protocol Number: 7655A-013 Start Date*: 2015-08-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Im...
    Medical condition: imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infect...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) RO (Completed) LT (Completed) GR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001585-15 Sponsor Protocol Number: 2018-01671 Start Date*: 2020-01-30
    Sponsor Name:Centre Hospitalier Universitaire Vaudois
    Full Title: PTX3 genetically stratified randomized double-blinded allocation eventdriven clinical trial for antifungal prophylaxis in patients with acute myeloid leukemia
    Medical condition: Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome in transformation (MDSit) who receive antifungal profylaxis during their treatment with an intensive chemotherapy regimen, inc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000338-20 Sponsor Protocol Number: MK-7655A-021 Start Date*: 2019-06-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Tha...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) Outside EU/EEA ES (Completed) BG (Completed) GR (Completed) NO (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001386-33 Sponsor Protocol Number: APX001-202 Start Date*: 2019-08-20
    Sponsor Name:Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer, Inc.
    Full Title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of APX001 in the Treatment of Patients with Invasive Mold Infections Caused by Aspergillus Species or Rare Molds
    Medical condition: Treatment of patients with invasive mold infections (IMIs) caused by Aspergillus species (spp.) or rare molds
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10062642 Invasive mycosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003202-82 Sponsor Protocol Number: MK7655A-016 Start Date*: 2019-07-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Pip...
    Medical condition: Hospital-Acquired Bacterial Pneumonia / Ventilator-Associated Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2015-000246-34 Sponsor Protocol Number: 7655A-014 Start Date*: 2015-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/T...
    Medical condition: Treatment for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) BG (Completed) PT (Completed) LT (Completed) FR (Completed) ES (Completed) HR (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003699-11 Sponsor Protocol Number: GN17RM684 Start Date*: 2019-06-13
    Sponsor Name:NHS Greater Glasgow and Clyde
    Full Title: Asthma Exacerbation Profile in patients on open label treatment with Benralizumab for severe eosinophilic asthma - an exploratory cohort study
    Medical condition: Severe Eosinophilic Asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10068462 Eosinophilic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-000219-15 Sponsor Protocol Number: 13-10 Start Date*: 2014-11-27
    Sponsor Name:VU Medical Center
    Full Title: Amyloid pathology in cognitively normal elderly subjects
    Medical condition: Cognitively healthy elderly, aged 60-100 years old.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002635-15 Sponsor Protocol Number: 15-06 Start Date*: 2016-07-28
    Sponsor Name:VU Medical Center
    Full Title: Study to Identify Factors associated with Resilience to Clinical Dementia at Old Age
    Medical condition: The protective factors of Alzheimer's disease in subjects aged 90 years and older
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003077-26 Sponsor Protocol Number: IMIVER Start Date*: 2012-08-13
    Sponsor Name:Department of Neurology, Odense University Hospital
    Full Title: Topical lidocaine for the treatment of focal peripheral neuropathic pain: response in relation to pain phenotype
    Medical condition: Chronic peripheral neuropathic pain caused by postherpetic neuralgia and traumatic/surgical nerve injury
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10054095 Neuropathic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000040-30 Sponsor Protocol Number: 202100912 Start Date*: 2023-03-06
    Sponsor Name:University Medical Center Groningen
    Full Title: An open label pilot study of [18AlF]-Resca-IL2 (Interleukin-2 PET tracer) for positron emission tomography imaging in patients treated with immune checkpoint inhibitors.
    Medical condition: patients with stage IV non-small-cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), CSCC, urothelial cell cancer (UCC), and head and neck squamous cell carcinoma (HNSCC), eligible for ICI the...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004494-81 Sponsor Protocol Number: PNB02-C201 Start Date*: 2012-03-29
    Sponsor Name:Pharmaneuroboost N.V.
    Full Title: Proof-of-Concept Study of Pipamperone 15mg added to Stable Treatment with Risperidone or Paliperidone in Chronic Schizophrenic and Schizoaffective Patients with Residual Symptoms: a phase I/IIa, r...
    Medical condition: Schizophrenia or Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-R criteria.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10009134 Chronic schizophrenia LLT
    14.1 10037175 - Psychiatric disorders 10039621 Schizoaffective disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002611-25 Sponsor Protocol Number: SP791 Start Date*: 2005-11-24
    Sponsor Name:SCHWARZ BIOSCIENCES GmBH
    Full Title: An open label extension trial to investigate the safety and tolerability of long-term treatment with transdermal rotigotine in subjects with idiopathic restless legs syndrome
    Medical condition: Idiopathic restless legs syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) SE (Completed) ES (Completed) FI (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003712-23 Sponsor Protocol Number: CLAF237A23156 Start Date*: 2012-03-14
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 5-year study to compare the durability of glycemic control of a combination regimen with vildagliptin & metformin versus standard-of-care monotherapy with metformin, initiated in treatment-naive...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) FI (Completed) LV (Completed) IT (Completed) HU (Completed) DE (Completed) EE (Completed) SK (Completed) BG (Completed) PL (Completed) NO (Completed) CZ (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-000942-21 Sponsor Protocol Number: AIMS-2-CT1 Start Date*: 2019-07-24
    Sponsor Name:Celso Arango
    Full Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents w...
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-000635-40 Sponsor Protocol Number: SP1005 Start Date*: 2016-03-16
    Sponsor Name:UCB BIOSCIENCES, Inc.
    Full Title: AN OPEN-LABEL, LONG-TERM FOLLOW-UP STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND EFFICACY OF ROTIGOTINE TRANSDERMAL SYSTEM AS MONOTHERAPY IN ADOLESCENTS WITH RESTLESS LEGS SYNDROME
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-003661-33 Sponsor Protocol Number: 182-026 Start Date*: 2005-01-19
    Sponsor Name:Sepracor, Inc.
    Full Title: A Pilot Study of the Safety and Efficacy of SEP-226330 in Subjects with Restless Legs Syndrome
    Medical condition: Restless Legs Syndrome (RLS)
    Disease: Version SOC Term Classification Code Term Level
    7.1 10038741 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IS (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004383-37 Sponsor Protocol Number: SP1004 Start Date*: 2015-04-08
    Sponsor Name:UCB BIOSCIENCES, Inc.
    Full Title: A Multicenter, Open-Label, 2-Group, Dose Escalation Study of Monotherapy Administration of Rotigotine in Pediatric Subjects With Idiopathic Restless Legs Syndrome
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002879-14 Sponsor Protocol Number: BioVacSafe-Boostrix® Start Date*: 2015-07-30
    Sponsor Name:Ghent University Hospital
    Full Title: BioVacSafe-Boostrix®: een klinische studie om een reeks gegevens te regenereren die kenmerkend zijn voor klinische gebeurtenissen, fysiologische reacties en aangeboren en adaptieve immuunreacties v...
    Medical condition: vaccin against diphtheria, tetanus and pertussis.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10046859 Vaccination LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
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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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