72. 下垂体性ADH分泌異常症 Pituitary ADH secretion disorder Clinical trials / Disease details


臨床試験数 : 40 薬物数 : 28 - (DrugBank : 7) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 9

  
14 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04790175
(ClinicalTrials.gov)
March 29, 202125/2/2021Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADHSamsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in JapanAntidiuretic Hormone, Inappropriate SecretionDrug: Tolvaptan (SAMSCA)Otsuka Pharmaceutical Co., Ltd.NULLRecruitingN/AN/AAll300Japan
2JPRN-JapicCTI-173512
02/3/201708/02/2017Tolvaptan SIADH StudyA Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate theEfficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia inSyndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) Syndrome of inappropriate secretion of antidiuretic hormones (SIADH)Intervention name : Tolvaptan
INN of the intervention : -
Dosage And administration of the intervention : Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.

Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Otsuka Pharmaceutical Co., LTD.NULLcomplete2085BOTH16Phase 3Japan
3NCT03048747
(ClinicalTrials.gov)
March 2, 20177/2/2017A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADHA Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)Syndrome of Inappropriate Antidiuretic Hormone SecretionDrug: Tolvaptan Oral TabletOtsuka Pharmaceutical Co., Ltd.NULLCompleted20 Years85 YearsAll16Phase 3Japan
4NCT02545114
(ClinicalTrials.gov)
August 20152/9/2015Tolvaptan for Patients With Acute Neurological InjuriesUse of Tolvaptan to Treat SIADH-induced Hyponatremia in Selected Patients With Acute Neurological InjuriesHyponatremia;SIADHDrug: TolvaptanPolderman, Kees, H., MD, PhDUniversity of PittsburghTerminated18 YearsN/AAll25N/AUnited States
5EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
6EUCTR2013-003800-38-DK
(EUCTR)
24/02/201409/12/2013The effects of tolvaptan on renal handeling of water and salt, hormones in the blood and the circulation, during blocking of the nitric oxide (NO) system in healthy subjects. A dose-response study.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 subjects. A dose-response study. - DOVA HyponatremiaSIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion)
MedDRA version: 14.1;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 14.1;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
22Phase 2Denmark
7NCT02009878
(ClinicalTrials.gov)
November 20139/12/2013A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone SecretionSyndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)Drug: tolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 YearsN/AAll30Phase 1/Phase 2Czech Republic;Denmark;Germany;Hungary;Spain;Sweden;United Kingdom
8EUCTR2012-004071-39-IT
(EUCTR)
16/10/201231/10/2012Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders.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 restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders. Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
MedDRA version: 14.1;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: SAMSCA*10CPR 15MG
INN or Proposed INN: TOLVAPTAN
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
9EUCTR2012-001169-33-DK
(EUCTR)
02/07/201214/06/2012Effects of the diuretic tolvaptan on nitric oxide systemEffects of tolvaptan on renal sodium and water handling and circulation during inhibition of the nitric oxide system in healthy subjects - SAFA SIADH (Syndrome of inappropriate ADH production)OverhydrationHyponatrimia
MedDRA version: 14.1;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 14.1;Classification code 10040626;Term: SIADH;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
10NCT01425125
(ClinicalTrials.gov)
November 201125/8/2011Fractional Urate Excretion in Nonedematous HyponatremiaStudy of Nonedematous Hyponatremia and the Utility of Fractional Urate Excretion in Hyponatremia and Suspected Renal Salt Wasting Without Hyponatremia-Cerebral Hyponatremia;SIADH;Cerebral Salt-wasting Syndrome;Reset Hypothalamic OsmostatDrug: Tolvaptan in euvolemic hyponatremiaNYU Langone HealthNULLWithdrawn18 YearsN/AAll0N/AUnited States
11NCT01228682
(ClinicalTrials.gov)
October 201025/10/2010Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical PracticeA Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical PracticeSIADH;Non-SIADH Hyponatremia;Non-HyponatremiaDrug: TolvaptanOtsuka Frankfurt Research Institute GmbHNULLActive, not recruitingN/AN/ABoth200N/ADenmark;Germany;Italy;Norway;Spain;Sweden;United Kingdom
12NCT01227512
(ClinicalTrials.gov)
October 201022/10/2010Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional HyponatremiaPhase 3b, Multicenter, Randomized, Single-blind, Parallel Group Trial of the Effects of Titrated Oral SAMSCA(r) (Tolvaptan) 15, 30, or 60 mg QD Compared to Placebo Plus Fluid Restriction on Length of Hospital Stay and Symptoms in Subjects Hospitalized With Dilutional HyponatremiaHyponatremia;Dilutional Hyponatremia;Inappropriate ADH SyndromeDrug: tolvaptan;Other: Fluid RestrictionOtsuka Pharmaceutical Development & Commercialization, Inc.NULLTerminated18 YearsN/AAll124Phase 3United States
13NCT00201994
(ClinicalTrials.gov)
November 200313/9/2005SALT-2 Trial Study of Ascending Levels of Tolvaptan in HyponatremiaMulticenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With Hyponatremia, Study 2Hyponatremia;Water Intoxication;Inappropriate ADH Syndrome;Water-electrolyte ImbalanceDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 YearsN/ABoth243Phase 3Germany
14NCT00072683
(ClinicalTrials.gov)
April 20037/11/2003SALT Trial” Study of Ascending Levels of Tolvaptan in HyponatremiaMulticenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With HyponatremiaHyponatremias;Water Intoxication;Inappropriate ADH Syndrome;Water-Electrolyte ImbalancesDrug: tolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 YearsN/ABoth240Phase 3United States