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 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:3] 

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. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03202667December 15, 201711 February 2019Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx StudyEffects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx StudySIAD - Syndrome of Inappropriate Antidiuresis;HyponatremiaDrug: Empagliflozin 25mg;Drug: PlaceboUniversity Hospital, Basel, SwitzerlandRecruiting18 YearsN/AAll16Phase 2/Phase 3Switzerland
2NCT03048747March 2, 20177 October 2019A 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.Not recruiting20 Years85 YearsAll16Phase 3Japan
3NCT02874807September 5, 201624 June 2019Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND StudyEffects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND StudySIADHOther: Placebo;Drug: EmpagliflozinUniversity Hospital, Basel, SwitzerlandNot recruiting18 Years84 YearsAll88Phase 2/Phase 3Switzerland
4NCT02729766March 201622 August 2016Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE StudyEffects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE StudyInappropriate ADH SyndromeOther: Induced hypotonic hyponatremia - SIAD model;Drug: Empagliflozin 25mg Tbl;Drug: Placebo P-TabletUniversity Hospital, Basel, SwitzerlandNot recruiting18 Years65 YearsBoth15Phase 2/Phase 3Switzerland
5NCT02545114August 20151 October 2018Tolvaptan 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 PittsburghNot recruiting18 YearsN/AAll25N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-001973-15-DK18/11/201411 April 2016The 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 - TOPOHyponatreamia 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 ResearchNot RecruitingFemale: yes
Male: yes
Denmark
7EUCTR2013-003800-38-DK24/02/20146 January 2015The 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. - DOVAHyponatremia 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 ResearchNot RecruitingFemale: yes
Male: yes
22Denmark
8NCT02009878November 201319 October 2017A 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.Not recruiting18 YearsN/AAll30Phase 1/Phase 2Czech Republic;Denmark;Germany;Hungary;Spain;Sweden;United Kingdom
9EUCTR2012-004071-39-IT16/10/201210 February 2014Study 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 MILANOAuthorisedFemale: yes
Male: yes
Italy
10EUCTR2012-001169-33-DK02/07/20121 December 2014Effects 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 - SAFASIADH (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 ResearchNot RecruitingFemale: yes
Male: yes
Denmark
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01425125November 201125 February 2019Fractional 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 hyponatremiaNew York University School of MedicineNot recruiting18 YearsN/AAll0N/AUnited States
12NCT01280188January 201119 February 2015A 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 PatientsCentral Diabetes InsipidusDrug: Desmopressin intranasal;Drug: Desmopressin Oral MeltFerring PharmaceuticalsNot recruiting6 Years75 YearsBoth20Phase 3Japan
13NCT01227512October 201019 October 2017Effects 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.Not recruiting18 YearsN/AAll124Phase 3United States
14NCT01228682October 201019 February 2015Post-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 GmbHNot recruitingN/AN/ABoth200N/ADenmark;Germany;Italy;Norway;Spain;Sweden;United Kingdom
15EUCTR2007-007941-10-DE11/06/20089 October 2012A 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 IDilutional 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 développementNot RecruitingFemale: yes
Male: yes
129Hungary;Germany;Belgium;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2004-005239-25-HU06/07/200519 March 2012An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH SafetyAn open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH SafetySyndrome 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 ResearchNot RecruitingFemale: yes
Male: yes
55Hungary;Germany;Spain
17NCT00264914July 200519 February 2015Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionAn Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome;HyponatremiaDrug: SR121463BSanofiNot recruiting18 YearsN/ABoth57Phase 3United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland
18EUCTR2004-003985-14-HU23/05/200519 March 2012A 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 HyponatremiaA 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 HyponatremiaDilutional 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 ResearchNot RecruitingFemale: yes
Male: yes
150Hungary;Denmark;Sweden
19EUCTR2004-002349-11-ES03/11/200419 March 2012A 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. - SIADHA 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. - SIADHSíndrome de secreción inadecuada de hormona antidiuréticaProduct 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 ResearchAuthorisedFemale: yes
Male: yes
75Spain
20NCT00264927May 200419 February 2015Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionA Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionInappropriate ADH Syndrome;HyponatremiaDrug: SR121463BSanofiNot recruiting18 YearsN/ABoth77Phase 3United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00201994November 200319 February 2015SALT-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.Not recruiting18 YearsN/ABoth243Phase 3Germany
22NCT00072683April 200319 February 2015“SALT 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.Not recruiting18 YearsN/ABoth240Phase 3United States
23NCT00032734June 200119 February 2015Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone SecretionA 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;HyponatremiaDrug: satavaptan (SR121463B)SanofiNot recruiting18 YearsN/ABoth35Phase 2Belgium;France;Germany;Hungary;United States;Canada

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