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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
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agemin
Inclusion_
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Inclusion_
gender
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PhaseCountries
1NCT04789148
(ClinicalTrials.gov)
June 20235/3/2021Effects of Intranasal Oxytocin in Patients With Central Diabetes InsipidusEffects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot StudyCentral Diabetes InsipidusDrug: Oxytocin nasal sprayElizabeth Austen LawsonNULLNot yet recruiting18 Years60 YearsAll30Phase 1United States
2NCT05319301
(ClinicalTrials.gov)
April 1, 202217/3/2022Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)Identification and Clinical Relevance of an Oxytocin Deficient State Following Melatonin Administration in Patients With Hypopituitarism: a Proof-of-concept, Physiopathological Study With a Control GroupOxytocin Deficiency;Hypopituitarism;Hypothalamic Obesity;Pituitary Dysfunction;Central Diabetes Insipidus;Social IsolationDietary Supplement: MelatoninFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauNULLNot yet recruiting18 YearsN/AAll40N/ASpain
3NCT04588207
(ClinicalTrials.gov)
March 29, 20227/10/2020Urea for Chronic HyponatremiaUrea for Chronic Hyponatremia: A Pilot StudyHyponatremia;Inappropriate ADH SyndromeDrug: UreaHelbert Rondon Berrios, MD, MSNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 YearsN/AAll30Phase 2United States
4NCT04897802
(ClinicalTrials.gov)
September 13, 202117/5/2021Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept, Physiopathological Study (GLP1 Study)Hypopituitarism;Central Diabetes Insipidus;Panhypopituitarism;Psychological Disorder;Social Isolation;Hypothalamic Diseases;Pituitary Diseases;Oxytocin DeficiencyDrug: Experimental: GLP1-RA (exenatide) administration;Drug: Control: Placebo administrationFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauInstituto de Salud Carlos IIIRecruiting18 Years65 YearsAll52Phase 4Spain
5NCT04902235
(ClinicalTrials.gov)
July 6, 202117/5/2021Identification and Clinical Relevance of an Oxytocin Deficient State (CRH Study)Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept Physiopathological Study (CRH Study)Hypopituitarism;Central Diabetes Insipidus;Panhypopituitarism;Psychological Disorder;Social Isolation;Hypothalamic Diseases;Pituitary Diseases;Oxytocin DeficiencyDrug: Experimental: CRH administration;Drug: Control: Placebo administrationFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauInstituto de Salud Carlos IIIRecruiting18 Years65 YearsAll52Phase 4Spain
6NCT04790175
(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
7NCT04447911
(ClinicalTrials.gov)
February 4, 202110/6/2020Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic HyponatremiaEffects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)Hyponatremia;SIADH;Liver Failure;Kidney FailureDrug: Empagliflozin 25 MG;Drug: PlaceboUniversity Hospital, Basel, SwitzerlandLuzerner Kantonsspital;Centre Hospitalier Universitaire VaudoisRecruiting18 YearsN/AAll172Phase 4Switzerland
8NCT04552873
(ClinicalTrials.gov)
December 3, 202010/9/2020Urea Therapy for Hyponatremia in Subarachnoid HemorrhageUrea Therapy for Hyponatremia in Subarachnoid HemorrhageHyponatremia;Subarachnoid Hemorrhage;SIADHDrug: Urea;Other: PLACEBOUniversity Hospital, GrenobleNULLRecruiting18 YearsN/AAll52N/AFrance
9NCT03202667
(ClinicalTrials.gov)
December 15, 201727/6/2017Effects 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, SwitzerlandNULLCompleted18 YearsN/AAll17Phase 2/Phase 3Switzerland
10NCT03048747
(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
11JPRN-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
12NCT02874807
(ClinicalTrials.gov)
September 5, 201617/8/2016Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND StudyEffects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND StudySIADHDrug: Empagliflozin;Other: PlaceboUniversity Hospital, Basel, SwitzerlandNULLCompleted18 Years84 YearsAll88Phase 2/Phase 3Switzerland
13NCT02729766
(ClinicalTrials.gov)
March 201624/3/2016Effects 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, SwitzerlandNULLCompleted18 Years65 YearsBoth15Phase 2/Phase 3Switzerland
14NCT02545114
(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
15EUCTR2014-001973-15-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
16EUCTR2013-003800-38-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
17NCT02009878
(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
18EUCTR2012-004071-39-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
19EUCTR2012-001169-33-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
20NCT01425125
(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
21NCT01280188
(ClinicalTrials.gov)
January 201119/1/2011A 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 Oral Melt;Drug: Desmopressin intranasalFerring PharmaceuticalsNULLCompleted6 Years75 YearsBoth20Phase 3Japan
22NCT01228682
(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
23NCT01227512
(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
24EUCTR2007-007941-10-BE
(EUCTR)
10/09/200802/07/2008A 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 IA 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
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129France;Hungary;Belgium;Germany
25EUCTR2007-007941-10-HU
(EUCTR)
04/08/200812/06/2008A 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: 9.1;Level: LLT;Classification code 10021036;Term: Hyponatraemia
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Hungary;Germany;Belgium;France
26NCT00728091
(ClinicalTrials.gov)
July 200831/7/2008A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional HyponatremiaA 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)Hyponatremia;Inappropriate ADH SyndromeDrug: satavaptan (SR121463);Drug: placeboSanofiNULLTerminated18 YearsN/ABoth2Phase 3United States
27EUCTR2007-007941-10-FR
(EUCTR)
16/06/200815/04/2008A 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 IA 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
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Phase 3France;Hungary;Belgium;Germany
28EUCTR2007-007941-10-DE
(EUCTR)
11/06/200802/04/2008A 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
INN or Proposed INN: satavaptan
Product Name: satavaptan
Product Code: SR121463B
INN or Proposed INN: satavaptan
sanofi-aventis recherche et développementNULLNot RecruitingFemale: yes
Male: yes
129Hungary;Germany;Belgium;France
29EUCTR2004-003985-14-DK
(EUCTR)
19/09/200505/07/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
108Hungary;Denmark;Sweden
30EUCTR2004-005239-25-DE
(EUCTR)
30/08/200516/06/2005An 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
55Hungary;Germany;Spain
31EUCTR2004-003985-14-SE
(EUCTR)
24/08/200520/06/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
108Hungary;Denmark;Sweden
32EUCTR2004-005239-25-HU
(EUCTR)
06/07/200511/05/2005An 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
55Hungary;Germany;Spain
33NCT00264914
(ClinicalTrials.gov)
July 200512/12/2005Safety 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: SR121463BSanofiNULLCompleted18 YearsN/ABoth57Phase 3United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland
34EUCTR2004-003985-14-BE
(EUCTR)
09/06/200520/05/2005A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - DILIPOA Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - DILIPO Dilutional hyponatremia excluding known syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1;Level: LLT;Classification code 10021038
Trade Name: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Trade Name: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Hungary;Belgium;Denmark;Sweden
35EUCTR2004-003985-14-HU
(EUCTR)
23/05/200513/04/2005A 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
150Hungary;Denmark;Sweden
36EUCTR2004-005239-25-ES
(EUCTR)
19/05/200527/04/2006An 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 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
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Product Name: NA
Product Code: SR121463B
INN or Proposed INN: NA
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
Phase 3Hungary;Spain;Germany
37EUCTR2004-002349-11-ES
(EUCTR)
03/11/200414/10/2004A 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. - SIADH Síndrome de secreción inadecuada de hormona antidiuréticaProduct Code: SR121463B
INN or Proposed INN: IUPAC
INN or Proposed INN: IUPAC
Sanofi-Synthelabo ResearchNULLNot RecruitingFemale: yes
Male: yes
75Phase 3Spain
38NCT00264927
(ClinicalTrials.gov)
May 200412/12/2005Efficacy 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: SR121463BSanofiNULLCompleted18 YearsN/ABoth77Phase 3United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain
39NCT00201994
(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
40NCT00072683
(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
41NCT00032734
(ClinicalTrials.gov)
June 200129/3/2002Efficacy 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)SanofiNULLCompleted18 YearsN/ABoth35Phase 2Belgium;France;Germany;Hungary;United States;Canada