TOLVAPTAN ( DrugBank: Tolvaptan )

4 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
67	多発性嚢胞腎	80
72	下垂体性ADH分泌異常症	14
86	肺動脈性肺高血圧症	1
225	先天性腎性尿崩症	3

67. 多発性嚢胞腎

臨床試験数 : 221 / 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151

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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	NCT05190744 (ClinicalTrials.gov)	September 1, 2022	29/12/2021	PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Po ...	A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine O ...	Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Dia ...	Drug: PB	Mayo Clinic	Hopital du Sacre-Coeur de Montreal	Recruiting	18 Years	N/A	All	20	Phase 2	United States
2	NCT04782258 (ClinicalTrials.gov)	July 15, 2022	19/2/2021	A Study to See if Tolvaptanis Safe in Infants and Children Who at Enrollment Are 28 Days to Less Tha ...	A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptanin Inf ...	Autosomal Recessive Polycystic Kidney (ARPKD)	Drug: Tolvaptan Suspension;Drug: Tolvaptan Tablets	Otsuka Pharmaceutical Development & Commercialization, Inc.	NULL	Recruiting	28 Days	18 Years	All	10	Phase 3	United States;Belgium;France;Germany;Italy;Poland;United Kingdom
3	NCT04786574 (ClinicalTrials.gov)	July 1, 2022	19/2/2021	A Study to See if TolvaptanCan Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days ...	A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptanin Inf ...	Autosomal Recessive Polycystic Kidney Disease (ARPKD)	Drug: Tolvaptan (OPC-41061)	Otsuka Pharmaceutical Development & Commercialization, Inc.	NULL	Recruiting	28 Days	12 Weeks	All	20	Phase 3	United States;Belgium;Germany;Italy;United Kingdom
4	ITMCTR2200005823	2022-04-15	2022-04-07	A multicenter cohort study of Tovastan combined with Shenfu Xiaozheng Decoction in the treatment of ...	A multicenter cohort study of Tovastan combined with Shenfu Xiaozheng Decoction in the treatment of ...	ADPKD	3:Tolvaptan+traditional Chinese medicine;1:Basic Western medicine treatment;4:traditional Chinese me ...	Hangzhou hospital of Traditional Chinese Medicine	NULL	Pending	18	70	Both	3:10;1:10;4:10;2:10;	Phase 1	China
5	ChiCTR2200058370	2022-04-15	2022-04-07	A multicenter cohort study of Tovastan combined with Shenfu Xiaozheng Decoction in the treatment of ...	A multicenter cohort study of Tovastan combined with Shenfu Xiaozheng Decoction in the treatment of ...	ADPKD	1:Basic Western medicine treatment;2:Tolvaptan;3:Tolvaptan+traditional Chinese medicine;4:traditiona ...	Hangzhou hospital of Traditional Chinese Medicine	NULL	Pending	18	70	Both	1:10;2:10;3:10;4:10;	Phase 1	China
6	JPRN-UMIN000046275	2021/12/11	06/12/2021	The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan ...	The effect of dapagliflozin in autosomal dominant polycystic kidney disease patients using tolvaptan ...	Autosomal dominant polycystic kidney disease (ADPKD)	Dapagliflozin 10mg/day for 6 months No treatment for 6 months	Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine	Department of Nephrology, International University of Health and Welfare School of MedicineDivision ...	Recruiting	20years-old	Not applicable	Male and Female	30	Not selected	Japan
7	NCT04152837 (ClinicalTrials.gov)	September 2, 2020	31/10/2019	Safety of Lixivaptan in Subjects Previously Treated With Tolvaptanfor Autosomal Dominant Polycystic ...	An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who ...	Polycystic Kidney Disease, Adult;ADPKD	Drug: Lixivaptan	Palladio Biosciences	Centessa Pharmaceuticals plc	Terminated	18 Years	65 Years	All	7	Phase 3	United States
8	NCT03949894 (ClinicalTrials.gov)	July 1, 2019	16/4/2019	Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptanfor Managemen ...	Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptanfor Managemen ...	Autosomal Dominant Polycystic Kidney Disease (ADPKD)	Drug: Tolvaptan	Korea Otsuka Pharmaceutical Co., Ltd.	NULL	Completed	19 Years	50 Years	All	118	Phase 4	Korea, Republic of
9	JPRN-jRCTs031180259	01/04/2019	14/03/2019	Tolvaptan Intervention study and Genetic mutation of AutosomalDominant Polycystic Kidney Disease	TolvaptanIntervention study to Autosomal Dominant PolycysticKidney Disease patients without Genetic ...	ADPKD	Tolvaptan treatment	Horie Shigeo	NULL	Complete	>= 20age old	Not applicable	Both	10	N/A	Japan
10	NCT03764605 (ClinicalTrials.gov)	January 30, 2019	29/11/2018	Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease	Metformin vs Tolvaptanfor Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Ind ...	ADPKD	Drug: Metformin;Drug: Tolvaptan	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	NULL	Not yet recruiting	18 Years	50 Years	All	150	Phase 3	Italy

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72. 下垂体性ADH分泌異常症

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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04790175 (ClinicalTrials.gov)	March 29, 2021	25/2/2021	Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH	Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of I ...	Antidiuretic Hormone, Inappropriate Secretion	Drug: Tolvaptan (SAMSCA)	Otsuka Pharmaceutical Co., Ltd.	NULL	Recruiting	N/A	N/A	All	300		Japan
2	NCT03048747 (ClinicalTrials.gov)	March 2, 2017	7/2/2017	A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptanin Patients With Hyponatremia ...	A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety ...	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
3	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 ...	Syndrome of inappropriate secretion of antidiuretic hormones (SIADH)	Intervention name : Tolvaptan INN of the intervention : - Dosage And administration of the interventio ...	Otsuka Pharmaceutical Co., LTD.	NULL	complete	20	85	BOTH	16	Phase 3	Japan
4	NCT02545114 (ClinicalTrials.gov)	August 2015	2/9/2015	Tolvaptan for Patients With Acute Neurological Injuries	Use of Tolvaptanto Treat SIADH-induced Hyponatremia in Selected Patients With Acute Neurological Inj ...	Hyponatremia;SIADH	Drug: Tolvaptan	Polderman, Kees, H., MD, PhD	University of Pittsburgh	Terminated	18 Years	N/A	All	25	N/A	United States
5	EUCTR2014-001973-15-DK (EUCTR)	18/11/2014	27/06/2014	The effcts of tolvaptanon renal handling of water and salt, hormones in the blood at the circulation ...	Renal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of to ...	HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosoma ...	Trade Name: Samsca Product Name: Tolvaptan Product Code: C03XA01 INN or Proposed INN: Tolvaptan Other de ...	University Clinic in Nephrology and Hypertension, Department of Medical Research	NULL	Not Recruiting			Female: yes Male: yes			Denmark
6	EUCTR2013-003800-38-DK (EUCTR)	24/02/2014	09/12/2013	The effects of tolvaptanon renal handeling of water and salt, hormones in the blood and the circulat ...	The effects of tolvaptanon renal handling of water and sodium, vasoactive hormones and circulatory s ...	HyponatremiaSIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion) MedDRA version: 14.1;Le ...	Trade Name: Samsca Product Name: Tolvaptan Product Code: C03XA01 INN or Proposed INN: Tolvaptan Other de ...	Department of Medical Research	NULL	Not Recruiting			Female: yes Male: yes	22	Phase 2	Denmark
7	NCT02009878 (ClinicalTrials.gov)	November 2013	9/12/2013	A PK Study of 3 Dosages of Tolvaptanin Patients With Syndrome of Inappropriate Antidiuretic Hormone ...	A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and ...	Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)	Drug: tolvaptan	Otsuka Pharmaceutical Development & Commercialization, Inc.	NULL	Completed	18 Years	N/A	All	30	Phase 1/Phase 2	Czech Republic;Denmark;Germany;Hungary;Spain;Sweden;United Kingdom
8	EUCTR2012-004071-39-IT (EUCTR)	16/10/2012	31/10/2012	Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretio ...	Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due ...	Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic ho ...	Trade Name: SAMSCA*10CPR 15MG INN or Proposed INN: TOLVAPTAN	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
9	EUCTR2012-001169-33-DK (EUCTR)	02/07/2012	14/06/2012	Effects of the diuretic tolvaptan on nitric oxide system	Effects of tolvaptanon renal sodium and water handling and circulation during inhibition of the nitr ...	SIADH (Syndrome of inappropriate ADH production)OverhydrationHyponatrimia MedDRA version: 14.1;Level ...	Trade Name: Samsca Product Name: Tolvaptan INN or Proposed INN: Tolvaptan Other descriptive name: TOLVA ...	Department of Medical Research	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Denmark
10	NCT01425125 (ClinicalTrials.gov)	November 2011	25/8/2011	Fractional Urate Excretion in Nonedematous Hyponatremia	Study of Nonedematous Hyponatremia and the Utility of Fractional Urate Excretion in Hyponatremia and ...	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

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86. 肺動脈性肺高血圧症

臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

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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	NCT05569655 (ClinicalTrials.gov)	April 6, 2021	1/10/2022	Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH	Efficacy and Safety Evaluation of Tolvaptanin the Treatment of Patients With Right Heart Failure Cau ...	Pulmonary Arterial Hypertension;Randomized Controlled Trial	Drug: Tolvaptan;Drug: Furosemide	Chinese Pulmonary Vascular Disease Research Group	NULL	Recruiting	18 Years	N/A	All	100	N/A	China

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225. 先天性腎性尿崩症

臨床試験数 : 15 / 薬物数 : 48 - (DrugBank : 18) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 65

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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	NCT05190744 (ClinicalTrials.gov)	September 1, 2022	29/12/2021	PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Po ...	A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine O ...	Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Dia ...	Drug: PB	Mayo Clinic	Hopital du Sacre-Coeur de Montreal	Recruiting	18 Years	N/A	All	20	Phase 2	United States
2	JPRN-jRCTs031180369	12/04/2018	18/03/2019	Tolvaptan for nephrogenic diabetes insipidus	Exploratory study of tolvaptanuse for nephrogenic diabetes insipidus caused by mutation in vasopress ...	Nephrogenic diabetes insipidus Nephrogenic diabetes insipidus, polyuria;D018500	Starting tolvaptan from 60 mg and dose up to 90mg and 120mg in every 1 or 2 days.	Makita Noriko	NULL	Recruiting	>= 20age old	Not applicable	Both	3	Phase 1-2	Japan
3	JPRN-UMIN000021708	2016/04/18	18/04/2016	A study to evaluate effect and safety of Tolvaptanin Nephrogenic Diabetes Insipidus caused by mutati ...	A study to evaluate effect and safety of Tolvaptanin Nephrogenic Diabetes Insipidus caused by mutati ...	Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene	1) Administration of Tolvaptanonce per day (60mg/day, 90mg/day, 120mg/day), each dose for two days. 2 ...	Department of Nephrology and Endocrinology, The University of Tokyo Hospital	NULL	Recruiting	20years-old	Not applicable	Male and Female	3	Not selected	Japan

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