Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Initial volume of distribution

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   44336   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    60 result(s) found for: Initial volume of distribution. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2010-024387-17 Sponsor Protocol Number: CPI-CL-012 Start Date*: 2012-05-16
    Sponsor Name:Cumberland Pharmaceuticals Inc.
    Full Title: A Multi-center, Randomized, Open-Label, Parallel, Active-Comparator, Multiple Dose Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Pediatric Patients
    Medical condition: fever
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2023-000502-26 Sponsor Protocol Number: TAK-660-3001 Start Date*: 2025-02-13
    Sponsor Name:Baxalta US Inc.
    Full Title: A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleedi...
    Medical condition: Severe Hemophilia A (FVIII <1%)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000533-13 Sponsor Protocol Number: Randomet2017 Start Date*: 2019-12-05
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH
    Full Title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, stan...
    Medical condition: Stage IV childhood renal tumours
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) CZ (Ongoing) DK (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-023856-97 Sponsor Protocol Number: 205MS302 Start Date*: 2011-09-22
    Sponsor Name:Biogen Idec Limited
    Full Title: A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneo...
    Medical condition: Relapsing-remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-024541-67 Sponsor Protocol Number: 1 Start Date*: 2011-11-10
    Sponsor Name:NHS Greater Glasgow & Clyde R&D Office [...]
    1. NHS Greater Glasgow & Clyde R&D Office
    2. The University of Glasgow
    Full Title: Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis – pilot phase
    Medical condition: Acute Ischaemic Stroke
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-002756-21 Sponsor Protocol Number: 1663/2020 Start Date*: 2021-02-23
    Sponsor Name:Department of Cardiothoracic Anesthesia and Intensive Care Medicine, Medical University of Vienna
    Full Title: Plasma Pharmacokinetics of Prophylactic Cefazolin Administered for Cardiac Surgery: Comparison of Cardiopulmonary Bypass Priming with Additive Human Albumin 20% vs.Pure Crystalloid Priming: A singl...
    Medical condition: This is a pharmacokinetic trial for patients undergoing cardiac surgery. It will be investigated whether cardiopulmonary bypass priming substituted with human albumin 20% has an effect on the pharm...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000259-28 Sponsor Protocol Number: 54179060LYM3003 Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma.
    Medical condition: Mature B-Cell Neoplasm
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed) BE (Completed) CZ (Completed) HU (Completed) DE (Completed) NL (Completed) ES (Completed) PL (Completed) BG (Completed) Outside EU/EEA SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002366-40 Sponsor Protocol Number: 13.0095 Start Date*: 2013-07-19
    Sponsor Name:St George’s, University of London
    Full Title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials study
    Medical condition: The study is not restricted to any specific condition. The study population will include children (aged under 16 years) admitted to hospital and routinely prescribed one of the study penicillins ac...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-002000-31 Sponsor Protocol Number: FSJD-ISON-2016 Start Date*: 2016-09-21
    Sponsor Name:FUNDACIÓ SANT JOAN DE DÉU
    Full Title: Open clinical trial phase IIa to study the isoniazid suspension absoption of 10mg/ml for the tuberculosis infection treatment in patients under the age of 6
    Medical condition: tuberculosis infection in patients under the age of 6
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002312-27 Sponsor Protocol Number: 13-031 Start Date*: 2013-08-14
    Sponsor Name:Zealand Pharma
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients with ST-Elevation Myocardial Infarction undergoing Primary Per...
    Medical condition: The treatment of acute myocardial infarction, AMI is aimed at enabling the return of blood flow to the ischemic myocardium, thereby limiting the size of the infarct. However the reperfusion by itse...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10047065 - Vascular disorders 10063837 Reperfusion injury PT
    16.1 100000004849 10064345 ST segment elevation myocardial infarction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-001268-44 Sponsor Protocol Number: MDCO-CLV-12-01 Start Date*: 2013-09-10
    Sponsor Name:Chiesi USA, Inc.
    Full Title: Open label study to assess the efficacy, safety and dosing of clevidipine in pediatric patients undergoing surgery.
    Medical condition: Blood pressure management in pediatric patients in the perioperative setting. Treatment of hypertensive patients and normotensive patients who require lowering of blood pressure for the procedure.
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002756-27 Sponsor Protocol Number: N01349 Start Date*: Information not available in EudraCT
    Sponsor Name:UCB Biopharma SPRL
    Full Title: A multicenter, open-label, single-arm study to evaluate the pharmacokinetics, efficacy, and safety of brivaracetam in neonates with repeated electroencephalographic seizures
    Medical condition: Electroencephalographic neonatal seizures
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) BE (Prematurely Ended) CZ (Completed) HU (Completed) NL (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021955-14 Sponsor Protocol Number: BUP3030 Start Date*: 2011-10-17
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged from Birth to 6 Years of Age...
    Medical condition: Acute moderate to severe pain requiring opioids for at least 24 hours in postoperative and prolonged endotracheal intubated patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    14.0 10042613 - Surgical and medical procedures 10021415 Immediate postoperative analgesia LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003829-29 Sponsor Protocol Number: EMR200637-002 Start Date*: 2014-10-27
    Sponsor Name:Symphogen A/S
    Full Title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses versus Investigator`s Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects with Metastatic Color...
    Medical condition: Metastatic colorectal cancer with Acquired Resistance to Anti-EGFR Monoclonal Antibodies
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) BE (Completed) AT (Completed) HU (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000861-58 Sponsor Protocol Number: NP39761 Start Date*: 2019-10-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF IDASANUTLIN MONOTHERAPY IN PARTICIPANTS WITH HYDROXYUREA-RESISTANT/INTOLERANT POL...
    Medical condition: Polycythemia Vera (PV)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10036061 Polycythemia vera LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000826-22 Sponsor Protocol Number: CBLZ945C12201 Start Date*: 2019-09-17
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following m...
    Medical condition: Amyotrophic lateral sclerosis (ALS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002619-89 Sponsor Protocol Number: B1761031 Start Date*: 2019-06-05
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG™) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTOR...
    Medical condition: relapsed or refractory CD33-positive acute myeloid leukaemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-005651-21 Sponsor Protocol Number: ONC001-CL-001 Start Date*: 2021-05-26
    Sponsor Name:Oncorena AB
    Full Title: A phase I/II, open label, single arm study on safety, tolerability and anti -tumour efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma
    Medical condition: Metastatic Clear Cell Renal Cell Carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC) and with End-Stage Renal Disease (ESRD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10050513 Metastatic renal cell carcinoma PT
    22.0 100000004857 10038443 Renal failure and impairment HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021900-93 Sponsor Protocol Number: CLIN1001 PCM301 Start Date*: 2010-12-14
    Sponsor Name:STEBA BIOTECH SA
    Full Title: A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for low risk localised prostate cancer compared to Active Surveillance
    Medical condition: Low-risk prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    12.1 10060862 Prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) NL (Completed) BE (Completed) SE (Completed) FI (Completed) DK (Completed) ES (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024585-22 Sponsor Protocol Number: WILK3 Start Date*: 2011-03-25
    Sponsor Name:Imperial College Academic Healthsciences Centre
    Full Title: What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?
    Medical condition: Idiopathic or familial pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 19 11:26:26 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA