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Clinical trials for Tolvaptan

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 ).  
     
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    26 result(s) found for: Tolvaptan. Displaying page 1 of 2.
    1  2  Next»
    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: 2018-000477-77 Sponsor Protocol Number: AIFA-2016-02365060 Start Date*: 2018-11-08
    Sponsor Name:U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARI
    Full Title: Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial
    Medical condition: Autosomal Dominant Polycystic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004701-40 Sponsor Protocol Number: TOOL Start Date*: 2018-08-06
    Sponsor Name:IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    Full Title: A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE ...
    Medical condition: Autosomal Dominant Policiytic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002306-39 Sponsor Protocol Number: 156-03-236 Start Date*: 2005-07-15
    Sponsor Name:Otsuka Maryland Research Institute, Inc.
    Full Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized with Worsening Congestive Heart Failure
    Medical condition: Subjects hospitalized with worsening congestive heart failure (CHF).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000226-38 Sponsor Protocol Number: 156-13-210 Start Date*: 2015-01-08
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) SE (Completed) HU (Completed) DK (Completed) NL (Completed) BE (Completed) ES (Completed) CZ (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001516-19 Sponsor Protocol Number: 156-13-211 Start Date*: 2015-03-26
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization,
    Full Title: A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) SE (Completed) NL (Completed) BE (Completed) PL (Completed) ES (Completed) CZ (Completed) HU (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-001501-41 Sponsor Protocol Number: 156-13-208 Start Date*: 2016-01-16
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004115-39 Sponsor Protocol Number: PoCKET Start Date*: 2018-02-08
    Sponsor Name:Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology
    Full Title: Subacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease
    Medical condition: Autosomal Dominant Polycystic Kidney DIsease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036045 Polycystic kidney LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002768-24 Sponsor Protocol Number: 156-04-251 Start Date*: 2007-01-26
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) GB (Completed) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005992-10 Sponsor Protocol Number: 156-201-00307 Start Date*: Information not available in EudraCT
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidne...
    Medical condition: Autosomal Recessive Polycystic Kidney Disease (ARPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036047 Polycystic kidney, autosomal recessive LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    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: 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)
    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: 2016-000187-42 Sponsor Protocol Number: 156-12-298 Start Date*: 2016-10-24
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-l...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003864-10 Sponsor Protocol Number: NL2017HCTMet Start Date*: 2018-05-02
    Sponsor Name:University Medical Center Groningen
    Full Title: Hydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptan
    Medical condition: Autosomal dominant polycystic kidney disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018401-10 Sponsor Protocol Number: 156-08-271 Start Date*: 2010-07-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc
    Full Title: A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) GB (Completed) BE (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-019025-33 Sponsor Protocol Number: 156-09-284 Start Date*: 2010-08-31
    Sponsor Name:Otsuka Pharmaceutical Development Commercialization, Inc.
    Full Title: A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Domin...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-005991-36 Sponsor Protocol Number: 156-12-204 Start Date*: 2022-10-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 12 weeks of Age with Autosomal Recessive Polycystic Kidne...
    Medical condition: Autosomal Recessive Polycystic Kidney Disease (ARPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036047 Polycystic kidney, autosomal recessive LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    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: 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
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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
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