72. 下垂体性ADH分泌異常症 Pituitary ADH secretion disorder Clinical trials / Disease details
臨床試験数 : 41 / 薬物数 : 27 - (DrugBank : 8) / 標的遺伝子数 : 7 - 標的パスウェイ数 : 10
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04790175 (ClinicalTrials.gov) | March 29, 2021 | 25/2/2021 | Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH | Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan | Antidiuretic Hormone, Inappropriate Secretion | Drug: Tolvaptan (SAMSCA) | Otsuka Pharmaceutical Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 300 | Japan | |
| 2 | JPRN-JapicCTI-173512 | 02/3/2017 | 08/02/2017 | Tolvaptan SIADH Study | A 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. | NULL | complete | 20 | 85 | BOTH | 16 | Phase 3 | Japan |
| 3 | NCT03048747 (ClinicalTrials.gov) | March 2, 2017 | 7/2/2017 | A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH | A 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 Secretion | Drug: Tolvaptan Oral Tablet | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | 85 Years | All | 16 | Phase 3 | Japan |
| 4 | NCT02545114 (ClinicalTrials.gov) | August 2015 | 2/9/2015 | Tolvaptan for Patients With Acute Neurological Injuries | Use of Tolvaptan to Treat SIADH-induced Hyponatremia in Selected Patients With Acute Neurological Injuries | Hyponatremia;SIADH | Drug: Tolvaptan | Polderman, Kees, H., MD, PhD | University of Pittsburgh | Terminated | 18 Years | N/A | All | 25 | N/A | United States |
| 5 | EUCTR2014-001973-15-DK (EUCTR) | 18/11/2014 | 27/06/2014 | The 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 disease | Renal 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 Research | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 6 | EUCTR2013-003800-38-DK (EUCTR) | 24/02/2014 | 09/12/2013 | The 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 2 | Denmark | ||
| 7 | NCT02009878 (ClinicalTrials.gov) | November 2013 | 9/12/2013 | A 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 Secretion | Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) | Drug: tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | Czech Republic;Denmark;Germany;Hungary;Spain;Sweden;United Kingdom |
| 8 | EUCTR2012-004071-39-IT (EUCTR) | 16/10/2012 | 31/10/2012 | Study 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 MILANO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 9 | EUCTR2012-001169-33-DK (EUCTR) | 02/07/2012 | 14/06/2012 | Effects of the diuretic tolvaptan on nitric oxide system | Effects 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Denmark | ||
| 10 | NCT01425125 (ClinicalTrials.gov) | November 2011 | 25/8/2011 | Fractional Urate Excretion in Nonedematous Hyponatremia | Study 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 Osmostat | Drug: Tolvaptan in euvolemic hyponatremia | NYU Langone Health | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | United States |
| 11 | NCT01227512 (ClinicalTrials.gov) | October 2010 | 22/10/2010 | Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia | Phase 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 Hyponatremia | Hyponatremia;Dilutional Hyponatremia;Inappropriate ADH Syndrome | Drug: tolvaptan;Other: Fluid Restriction | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Terminated | 18 Years | N/A | All | 124 | Phase 3 | United States |
| 12 | NCT01228682 (ClinicalTrials.gov) | October 2010 | 25/10/2010 | Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice | A 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 Practice | SIADH;Non-SIADH Hyponatremia;Non-Hyponatremia | Drug: Tolvaptan | Otsuka Frankfurt Research Institute GmbH | NULL | Active, not recruiting | N/A | N/A | Both | 200 | N/A | Denmark;Germany;Italy;Norway;Spain;Sweden;United Kingdom |
| 13 | NCT00201994 (ClinicalTrials.gov) | November 2003 | 13/9/2005 | SALT-2 Trial Study of Ascending Levels of Tolvaptan in Hyponatremia | Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With Hyponatremia, Study 2 | Hyponatremia;Water Intoxication;Inappropriate ADH Syndrome;Water-electrolyte Imbalance | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | N/A | Both | 243 | Phase 3 | Germany |
| 14 | NCT00072683 (ClinicalTrials.gov) | April 2003 | 7/11/2003 | SALT Trial” Study of Ascending Levels of Tolvaptan in Hyponatremia | Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of the Effects of Titrated Oral Tolvaptan Tablets in Patients With Hyponatremia | Hyponatremias;Water Intoxication;Inappropriate ADH Syndrome;Water-Electrolyte Imbalances | Drug: tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | N/A | Both | 240 | Phase 3 | United States |