72. 下垂体性ADH分泌異常症 ［臨床試験数：23，薬物数：16（DrugBank：4），標的遺伝子数：2，標的パスウェイ数：4］
Searched query = "Pituitary ADH secretion disorder", "Inappropriate antidiuretic hormone secretion", "Syndrome of inappropriate secretion of antidiuretic hormone", "Inappropriate ADH syndrome", "Syndrome of inappropriate ADH", "Central diabetes insipidus", "Syndrome of inappropriate secretion of ADH", "SIADH"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03202667 | December 15, 2017 | 11 February 2019 | Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study | Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study | SIAD - Syndrome of Inappropriate Antidiuresis;Hyponatremia | Drug: Empagliflozin 25mg;Drug: Placebo | University Hospital, Basel, Switzerland | Recruiting | 18 Years | N/A | All | 16 | Phase 2/Phase 3 | Switzerland | |
| 2 | NCT03048747 | March 2, 2017 | 7 October 2019 | 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. | Not recruiting | 20 Years | 85 Years | All | 16 | Phase 3 | Japan | |
| 3 | NCT02874807 | September 5, 2016 | 24 June 2019 | Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study | Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study | SIADH | Other: Placebo;Drug: Empagliflozin | University Hospital, Basel, Switzerland | Not recruiting | 18 Years | 84 Years | All | 88 | Phase 2/Phase 3 | Switzerland | |
| 4 | NCT02729766 | March 2016 | 22 August 2016 | Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study | Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study | Inappropriate ADH Syndrome | Other: Induced hypotonic hyponatremia - SIAD model;Drug: Empagliflozin 25mg Tbl;Drug: Placebo P-Tablet | University Hospital, Basel, Switzerland | Not recruiting | 18 Years | 65 Years | Both | 15 | Phase 2/Phase 3 | Switzerland | |
| 5 | NCT02545114 | August 2015 | 1 October 2018 | 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 | Not recruiting | 18 Years | N/A | All | 25 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2014-001973-15-DK | 18/11/2014 | 11 April 2016 | 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 | Hyponatreamia SIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) Overhydration Autosomal dominant polycystic kidney disease MedDRA version: 17.0 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | University Clinic in Nephrology and Hypertension, Department of Medical Research | Not Recruiting | Female: yes Male: yes | Denmark | |||||
| 7 | EUCTR2013-003800-38-DK | 24/02/2014 | 6 January 2015 | 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 | Hyponatremia SIADH (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 Level: LLT 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Current Sponsor code: C03XA01 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: range Concentration number: 15-30 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Department of Medical Research | Not Recruiting | Female: yes Male: yes | 22 | Denmark | ||||
| 8 | NCT02009878 | November 2013 | 19 October 2017 | 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. | Not recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | Czech Republic;Denmark;Germany;Hungary;Spain;Sweden;United Kingdom | |
| 9 | EUCTR2012-004071-39-IT | 16/10/2012 | 10 February 2014 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: TOLVAPTAN CAS Number: 150683-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | Authorised | Female: yes Male: yes | Italy | |||||
| 10 | EUCTR2012-001169-33-DK | 02/07/2012 | 1 December 2014 | 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) Overhydration Hyponatrimia MedDRA version: 14.1 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT 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 Pharmaceutical Form: Tablet INN or Proposed INN: Tolvaptan CAS Number: 150683-30-0 Other descriptive name: TOLVAPTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Department of Medical Research | Not Recruiting | Female: yes Male: yes | Denmark | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT01425125 | November 2011 | 25 February 2019 | 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 | New York University School of Medicine | Not recruiting | 18 Years | N/A | All | 0 | N/A | United States | |
| 12 | NCT01280188 | January 2011 | 19 February 2015 | A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI). | Peroral Administration of Different Doses of Desmopressin Administered as a New Orally-Disintegrating Tablet and Desmopressin for Nasal Administration in the Treatment of CDI in Japanese Patients | Central Diabetes Insipidus | Drug: Desmopressin intranasal;Drug: Desmopressin Oral Melt | Ferring Pharmaceuticals | Not recruiting | 6 Years | 75 Years | Both | 20 | Phase 3 | Japan | |
| 13 | NCT01227512 | October 2010 | 19 October 2017 | 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. | Not recruiting | 18 Years | N/A | All | 124 | Phase 3 | United States | |
| 14 | NCT01228682 | October 2010 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 200 | N/A | Denmark;Germany;Italy;Norway;Spain;Sweden;United Kingdom | |
| 15 | EUCTR2007-007941-10-DE | 11/06/2008 | 9 October 2012 | 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 due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I | Dilutional hyponatraemia. MedRA term HYPONATRAEMIA MedDRA version: 10.1 Level: LLT Classification code 10021036 Term: | Product Name: satavaptan Product Code: SR121463B Pharmaceutical Form: Film-coated tablet INN or Proposed INN: satavaptan CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: satavaptan Product Code: SR121463B Pharmaceutical Form: Film-coated tablet INN or Proposed INN: satavaptan CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | sanofi-aventis recherche et développement | Not Recruiting | Female: yes Male: yes | 129 | Hungary;Germany;Belgium;France | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2004-005239-25-HU | 06/07/2005 | 19 March 2012 | An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety | An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety | Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L. MedDRA version: 7.1 Level: LLT Classification code 10040626 | Product Name: NA Product Code: SR121463B Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: NA Product Code: SR121463B Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12,5- Product Name: NA Product Code: SR121463B Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Sanofi-Synthelabo Research | Not Recruiting | Female: yes Male: yes | 55 | Hungary;Germany;Spain | ||||
| 17 | NCT00264914 | July 2005 | 19 February 2015 | Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | Inappropriate ADH Syndrome;Hyponatremia | Drug: SR121463B | Sanofi | Not recruiting | 18 Years | N/A | Both | 57 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland | |
| 18 | EUCTR2004-003985-14-HU | 23/05/2005 | 19 March 2012 | 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 Hyponatremia - Dilutional Hyponatremia | 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 Hyponatremia - Dilutional Hyponatremia | Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis MedDRA version: 7.1 Level: LLT Classification code 10021038 | Product Name: NA Product Code: SR121463B Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: NA Product Code: SR121463B Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 308145-17-7 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Sanofi-Synthelabo Research | Not Recruiting | Female: yes Male: yes | 150 | Hungary;Denmark;Sweden | ||||
| 19 | EUCTR2004-002349-11-ES | 03/11/2004 | 19 March 2012 | A randomisation, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion. - SIADH | A randomisation, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion. - SIADH | Síndrome de secreción inadecuada de hormona antidiurética | Product Code: SR121463B Pharmaceutical Form: Capsule* INN or Proposed INN: IUPAC CAS Number: 185913-78-4 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- INN or Proposed INN: IUPAC CAS Number: 185913-78-4 Current Sponsor code: SR121463B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Sanofi-Synthelabo Research | Authorised | Female: yes Male: yes | 75 | Spain | ||||
| 20 | NCT00264927 | May 2004 | 19 February 2015 | Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | Inappropriate ADH Syndrome;Hyponatremia | Drug: SR121463B | Sanofi | Not recruiting | 18 Years | N/A | Both | 77 | Phase 3 | United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT00201994 | November 2003 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 243 | Phase 3 | Germany |
| 22 | NCT00072683 | April 2003 | 19 February 2015 | “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. | Not recruiting | 18 Years | N/A | Both | 240 | Phase 3 | United States |
| 23 | NCT00032734 | June 2001 | 19 February 2015 | Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion. | Syndrome of Inappropriate ADH (SIADH) Secretion;Hyponatremia | Drug: satavaptan (SR121463B) | Sanofi | Not recruiting | 18 Years | N/A | Both | 35 | Phase 2 | Belgium;France;Germany;Hungary;United States;Canada |