Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Hyponatremia

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
     
    41 result(s) found for: Hyponatremia. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2006-001754-26 Sponsor Protocol Number: CK-LX3405 Start Date*: 2008-10-08
    Sponsor Name:Cardiokine Biopharma, LLC
    Full Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia
    Medical condition: Subjects with euvolemic hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021038 Hyponatremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003985-14 Sponsor Protocol Number: CPR-EFC5816-EN-E01 Start Date*: 2005-05-23
    Sponsor Name:Sanofi-Synthelabo Research
    Full Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional ...
    Medical condition: Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10021038 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2006-005422-23 Sponsor Protocol Number: LTS10208 Start Date*: 2007-05-15
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: An open-label, multicenter study evaluating the long-term safety of satavaptan (SR121463B) and maintenance of normonatremia in patients with dilutional hyponatremia who have previously been treated...
    Medical condition: Dilutional hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021036 Hyponatraemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-003191-21 Sponsor Protocol Number: CK-LX3430 Start Date*: 2009-08-20
    Sponsor Name:Cardiokine Biopharma, LLC
    Full Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia
    Medical condition: Euvolemic hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021038 Hyponatremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) IT (Completed) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-007941-10 Sponsor Protocol Number: EFC10102 Start Date*: 2008-06-11
    Sponsor Name:sanofi-aventis recherche et développement
    Full Title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia du...
    Medical condition: Dilutional hyponatraemia. MedRA term "HYPONATRAEMIA"
    Disease: Version SOC Term Classification Code Term Level
    10.1 10021036 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) HU (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016371-30 Sponsor Protocol Number: CK-LX3431 Start Date*: 2010-07-05
    Sponsor Name:Cardiokine Biopharma LLC
    Full Title: International, multi-center, study of a twenty-eight week, open-label, titrated oral lixivaptan administration in patients with chronic hyponatremia: extension to studies CK-LX3401, 3405, and 3430
    Medical condition: Chronic hyponatraemia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10021036 Hyponatraemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002567-62 Sponsor Protocol Number: CK-LX3401 Start Date*: Information not available in EudraCT
    Sponsor Name:Cardiokine Biopharma, LLC
    Full Title: THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
    Medical condition: Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021038 Hyponatremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SK (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024431-17 Sponsor Protocol Number: INSERT Start Date*: 2011-03-31
    Sponsor Name:IST. DI RICERCHE FARMACOLOG. M. NEGRI
    Full Title: A PILOT STUDY TO EVALUATE THE INCIDENCE OF HYPONATREMIA IN A MEDICAL-SURGICAL HOSPITAL AND TO EXPLORE THE EFFICACY AND SAFETY OF TOLVAPTAN IN THE CLINICAL PRACTICE
    Medical condition: Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10021036 Hyponatraemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001582-27 Sponsor Protocol Number: 156-13-207 Start Date*: Information not available in EudraCT
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Pilot Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Efficacy, and Pharmacokinetics of Titrated Oral SAMSCA® (Tolvaptan) in Children and Adolescent Subje...
    Medical condition: Euvolemic or Hypervolemic Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10021038 Hyponatremia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001084-83 Sponsor Protocol Number: 38RC19.189 Start Date*: 2020-09-25
    Sponsor Name:CHU Grenoble-Alpes
    Full Title: Urea treatment of hyponatremia during subarachnoid hemorrhage
    Medical condition: Hyponatremia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002810-11 Sponsor Protocol Number: 156-11-294 Start Date*: 2015-03-26
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated ...
    Medical condition: Euvolemic or Hypervolemic Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10021038 Hyponatremia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended) RO (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003701-25 Sponsor Protocol Number: 7035-CL-0014 Start Date*: 2013-12-09
    Sponsor Name:Tacurion Pharma Inc
    Full Title: A Phase II, Multicenter,Randomization, Double-Blind, Parallel Group, Placebo-Controlled, Forced Titration Proof of Concept Study to Assess Efficacy, Safety, Tolerability and the Therapeutic Ratio ...
    Medical condition: Nocturia associated with nocturnal polyuria
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10064016 Nocturnal polyuria LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000302-29 Sponsor Protocol Number: AlbuCAT Start Date*: 2019-07-31
    Sponsor Name:Fundació Clinic per a la Recerca Biomèdica
    Full Title: ALBUMIN FOR MANAGEMENT OF HYPERVOLEMIC HYPONATREMIA IN PATIENTS WITH DECOMPENSATED CIRRHOSIS. A PROOF OF CONCEPT STUDY
    Medical condition: HYPERVOLEMIC HYPONATREMIA IN PATIENTS WITH DECOMPENSATED CIRRHOSIS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10009211 Cirrhosis liver LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002005-59 Sponsor Protocol Number: 156-08-276 Start Date*: 2015-01-12
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA® (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subject...
    Medical condition: Euvolemic or Hypervolemic Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10021038 Hyponatremia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Prematurely Ended) IT (Prematurely Ended) CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004071-39 Sponsor Protocol Number: TOLV2012 Start Date*: 2012-10-16
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid ...
    Medical condition: Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10014698 - Endocrine disorders 10014698 Endocrine disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003800-38 Sponsor Protocol Number: SAFA-1-2014 Start Date*: 2014-02-24
    Sponsor Name:Department of Medical Research
    Full Title: The effects of tolvaptan on renal handling of water and sodium, vasoactive hormones and circulatory system, during basal conditions and during inhibition of the nitric oxide system in healthy subj...
    Medical condition: Hyponatremia SIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004861 10021038 Hyponatremia LLT
    14.1 100000004860 10040626 SIADH LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001169-33 Sponsor Protocol Number: SAFA-1-2012 Start Date*: 2012-07-02
    Sponsor Name:Department of Medical Research
    Full Title: Effects of tolvaptan on renal sodium and water handling and circulation during inhibition of the nitric oxide system in healthy subjects
    Medical condition: SIADH (Syndrome of inappropriate ADH production) Overhydration Hyponatrimia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10021038 Hyponatremia LLT
    14.1 10014698 - Endocrine disorders 10040626 SIADH LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001059-63 Sponsor Protocol Number: 2015.009 Start Date*: 2015-09-23
    Sponsor Name:Aalborg University
    Full Title: BONATHIAD - Bone Association with Thiazide Diuretics.
    Medical condition: The effect of bendroflumethiazide with potassium supplement when used as an adjuvant to oral bisphosphonates in the treatment of newly diagnosed osteoporosis among post-menopausal women above 50 ye...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031282 Osteoporosis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-000452-16 Sponsor Protocol Number: 156-03-244 Start Date*: 2004-08-02
    Sponsor Name:Otsuka Maryland Research Institute
    Full Title: International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to a...
    Medical condition: Ongoing hyponatraemia in euvolemic and hypervolemic states
    Disease: Version SOC Term Classification Code Term Level
    7 10021036 1.1
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022320-67 Sponsor Protocol Number: 2010-022320-67 Start Date*: 2010-10-22
    Sponsor Name:AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
    Full Title: USE OF TOLVAPTAN IN CLINICAL SYNDROMES CHARACTERIZED BY INAPPROPRIATE SECRETION OF ADH
    Medical condition: hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014412 HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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 09:58:23 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA