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 | NCT04789148 (ClinicalTrials.gov) | June 2023 | 5/3/2021 | Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus | Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus - A Pilot Study | Central Diabetes Insipidus | Drug: Oxytocin nasal spray | Elizabeth Austen Lawson | NULL | Not yet recruiting | 18 Years | 60 Years | All | 30 | Phase 1 | United States |
| 2 | NCT05319301 (ClinicalTrials.gov) | April 1, 2022 | 17/3/2022 | Identification 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 Group | Oxytocin Deficiency;Hypopituitarism;Hypothalamic Obesity;Pituitary Dysfunction;Central Diabetes Insipidus;Social Isolation | Dietary Supplement: Melatonin | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Not yet recruiting | 18 Years | N/A | All | 40 | N/A | Spain |
| 3 | NCT04588207 (ClinicalTrials.gov) | March 29, 2022 | 7/10/2020 | Urea for Chronic Hyponatremia | Urea for Chronic Hyponatremia: A Pilot Study | Hyponatremia;Inappropriate ADH Syndrome | Drug: Urea | Helbert Rondon Berrios, MD, MS | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 4 | NCT04897802 (ClinicalTrials.gov) | September 13, 2021 | 17/5/2021 | Identification 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 Deficiency | Drug: Experimental: GLP1-RA (exenatide) administration;Drug: Control: Placebo administration | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Instituto de Salud Carlos III | Recruiting | 18 Years | 65 Years | All | 52 | Phase 4 | Spain |
| 5 | NCT04902235 (ClinicalTrials.gov) | July 6, 2021 | 17/5/2021 | Identification 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 Deficiency | Drug: Experimental: CRH administration;Drug: Control: Placebo administration | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Instituto de Salud Carlos III | Recruiting | 18 Years | 65 Years | All | 52 | Phase 4 | Spain |
| 6 | 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 | |
| 7 | NCT04447911 (ClinicalTrials.gov) | February 4, 2021 | 10/6/2020 | Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia | Effects 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 Failure | Drug: Empagliflozin 25 MG;Drug: Placebo | University Hospital, Basel, Switzerland | Luzerner Kantonsspital;Centre Hospitalier Universitaire Vaudois | Recruiting | 18 Years | N/A | All | 172 | Phase 4 | Switzerland |
| 8 | NCT04552873 (ClinicalTrials.gov) | December 3, 2020 | 10/9/2020 | Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage | Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage | Hyponatremia;Subarachnoid Hemorrhage;SIADH | Drug: Urea;Other: PLACEBO | University Hospital, Grenoble | NULL | Recruiting | 18 Years | N/A | All | 52 | N/A | France |
| 9 | NCT03202667 (ClinicalTrials.gov) | December 15, 2017 | 27/6/2017 | 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 | NULL | Completed | 18 Years | N/A | All | 17 | Phase 2/Phase 3 | Switzerland |
| 10 | 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 |
| 11 | 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 |
| 12 | NCT02874807 (ClinicalTrials.gov) | September 5, 2016 | 17/8/2016 | 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 | Drug: Empagliflozin;Other: Placebo | University Hospital, Basel, Switzerland | NULL | Completed | 18 Years | 84 Years | All | 88 | Phase 2/Phase 3 | Switzerland |
| 13 | NCT02729766 (ClinicalTrials.gov) | March 2016 | 24/3/2016 | 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 | NULL | Completed | 18 Years | 65 Years | Both | 15 | Phase 2/Phase 3 | Switzerland |
| 14 | 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 |
| 15 | 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 | ||||
| 16 | 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 | ||
| 17 | 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 |
| 18 | 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 | ||||
| 19 | 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 | ||
| 20 | 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 |
| 21 | NCT01280188 (ClinicalTrials.gov) | January 2011 | 19/1/2011 | 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 Oral Melt;Drug: Desmopressin intranasal | Ferring Pharmaceuticals | NULL | Completed | 6 Years | 75 Years | Both | 20 | Phase 3 | Japan |
| 22 | 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 |
| 23 | 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 |
| 24 | EUCTR2007-007941-10-BE (EUCTR) | 10/09/2008 | 02/07/2008 | 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 | 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 INN or Proposed INN: satavaptan Product Name: satavaptan Product Code: SR121463B INN or Proposed INN: satavaptan | sanofi-aventis recherche et développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | France;Hungary;Belgium;Germany | |||
| 25 | EUCTR2007-007941-10-HU (EUCTR) | 04/08/2008 | 12/06/2008 | 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: 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 développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Hungary;Germany;Belgium;France | ||||
| 26 | NCT00728091 (ClinicalTrials.gov) | July 2008 | 31/7/2008 | A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia | 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) | Hyponatremia;Inappropriate ADH Syndrome | Drug: satavaptan (SR121463);Drug: placebo | Sanofi | NULL | Terminated | 18 Years | N/A | Both | 2 | Phase 3 | United States |
| 27 | EUCTR2007-007941-10-FR (EUCTR) | 16/06/2008 | 15/04/2008 | 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 | 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 INN or Proposed INN: satavaptan Product Name: satavaptan Product Code: SR121463B INN or Proposed INN: satavaptan | sanofi-aventis recherche et développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Phase 3 | France;Hungary;Belgium;Germany | ||
| 28 | EUCTR2007-007941-10-DE (EUCTR) | 11/06/2008 | 02/04/2008 | 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 INN or Proposed INN: satavaptan Product Name: satavaptan Product Code: SR121463B INN or Proposed INN: satavaptan | sanofi-aventis recherche et développement | NULL | Not Recruiting | Female: yes Male: yes | 129 | Hungary;Germany;Belgium;France | ||||
| 29 | EUCTR2004-003985-14-DK (EUCTR) | 19/09/2005 | 05/07/2005 | A 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 | A 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 & développement | NULL | Not Recruiting | Female: yes Male: yes | 108 | Hungary;Denmark;Sweden | |||
| 30 | EUCTR2004-005239-25-DE (EUCTR) | 30/08/2005 | 16/06/2005 | 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 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 55 | Hungary;Germany;Spain | |||
| 31 | EUCTR2004-003985-14-SE (EUCTR) | 24/08/2005 | 20/06/2005 | A 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 | A 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 & développement | NULL | Not Recruiting | Female: yes Male: yes | 108 | Hungary;Denmark;Sweden | |||
| 32 | EUCTR2004-005239-25-HU (EUCTR) | 06/07/2005 | 11/05/2005 | 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 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 55 | Hungary;Germany;Spain | |||
| 33 | NCT00264914 (ClinicalTrials.gov) | July 2005 | 12/12/2005 | 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 | NULL | Completed | 18 Years | N/A | Both | 57 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;France;Germany;Hong Kong;Hungary;Russian Federation;Switzerland |
| 34 | EUCTR2004-003985-14-BE (EUCTR) | 09/06/2005 | 20/05/2005 | A 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 | A 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 Research | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Hungary;Belgium;Denmark;Sweden | ||
| 35 | EUCTR2004-003985-14-HU (EUCTR) | 23/05/2005 | 13/04/2005 | 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 INN or Proposed INN: NA Product Name: NA Product Code: SR121463B INN or Proposed INN: NA | Sanofi-Synthelabo Research | NULL | Not Recruiting | Female: yes Male: yes | 150 | Hungary;Denmark;Sweden | |||
| 36 | EUCTR2004-005239-25-ES (EUCTR) | 19/05/2005 | 27/04/2006 | 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 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 Research | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Hungary;Spain;Germany | |||
| 37 | EUCTR2004-002349-11-ES (EUCTR) | 03/11/2004 | 14/10/2004 | 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 INN or Proposed INN: IUPAC INN or Proposed INN: IUPAC | Sanofi-Synthelabo Research | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Spain | ||
| 38 | NCT00264927 (ClinicalTrials.gov) | May 2004 | 12/12/2005 | 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 | NULL | Completed | 18 Years | N/A | Both | 77 | Phase 3 | United States;Belgium;Brazil;Canada;Croatia;Germany;Hong Kong;Hungary;Netherlands;Portugal;Spain |
| 39 | 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 |
| 40 | 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 |
| 41 | NCT00032734 (ClinicalTrials.gov) | June 2001 | 29/3/2002 | 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 | NULL | Completed | 18 Years | N/A | Both | 35 | Phase 2 | Belgium;France;Germany;Hungary;United States;Canada |