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Tolvaptan 15    (DrugBank: Tolvaptan)

3 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23
72下垂体性ADH分泌異常症0
225先天性腎性尿崩症0

67. 多発性嚢胞腎　［臨床試験数：186，薬物数：196（DrugBank：47），標的遺伝子数：35，標的パスウェイ数：146］
Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
23 / 186 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2018-000477-77-IT
(EUCTR)		08/11/201804/11/2020Evaluation of Metformin and Tolvaptan in slowing disease progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD)Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial - METROPOLIS Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Trade Name: ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL
Product Name: METFORMINA
Product Code: [METFORMINA]
INN or Proposed INN: METFORMINA
Other descriptive name: METFORMIN
Trade Name: JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE
Product Name: TOLVAPTAN 15
Product Code: [TOLVAPTAN 15]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE
Product Name: TOLVAPTAN 30
Product Code: [TOLVAPTAN 30]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG)
Product Name: TOLVAPTAN 45/15
Product Code: [TOLVAPTAN 45/15]
INN or Proposed INN: TOLVAPTAN
Other descriptive name: TOLVAPTAN
Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG)
Product Name: TOLVAPTAN 60/30
Product Code: [TOL		U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		150Phase 3Italy
2EUCTR2016-000187-42-GB
(EUCTR)		24/10/201606/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]		Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		100Phase 3Belgium;Germany;Italy;United Kingdom
3EUCTR2016-000187-42-IT
(EUCTR)		26/09/201612/05/2016A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]		Product Name: Tolvaptan 7.5 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 15mg Tablet
Product Name: Tolvaptan 15 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Trade Name: Jinarc® 30 Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		100Phase 3Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy
4EUCTR2014-001516-19-HU
(EUCTR)		02/05/201601/03/2016This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes		2500Phase 3United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden
5EUCTR2014-001516-19-CZ
(EUCTR)		06/04/201628/01/2016This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes		2500Phase 3United States;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2014-001516-19-SE
(EUCTR)		04/02/201605/11/2014This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes		2500Phase 3United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Netherlands;Germany;Sweden
7EUCTR2014-001516-19-ES
(EUCTR)		30/10/201511/09/2015This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLNot RecruitingFemale: yes
Male: yes		2500Phase 3United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
8EUCTR2014-000226-38-FR
(EUCTR)		16/10/201511/12/2015This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
9EUCTR2014-001516-19-FR
(EUCTR)		30/03/201507/01/2015This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		2500Phase 3bUnited States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
10EUCTR2014-000226-38-PL
(EUCTR)		10/03/201508/12/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Sweden
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11EUCTR2014-000226-38-CZ
(EUCTR)		21/01/201513/11/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
12EUCTR2014-000226-38-ES
(EUCTR)		02/01/201516/10/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
13EUCTR2014-000226-38-NL
(EUCTR)		22/12/201424/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
14EUCTR2014-000226-38-BE
(EUCTR)		17/12/201426/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
15EUCTR2014-001516-19-IT
(EUCTR)		10/12/201416/10/2014This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)		Otsuka Pharmaceutical Development & Commercialization,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		2500Phase 3bUnited States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
16EUCTR2014-000226-38-DK
(EUCTR)		02/12/201411/09/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
17EUCTR2014-000226-38-SE
(EUCTR)		21/11/201414/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
18EUCTR2014-000226-38-IT
(EUCTR)		11/11/201405/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		1300Phase 3bUnited States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
19EUCTR2014-000226-38-HU
(EUCTR)		03/11/201421/08/2014This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney diseaseA Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		1300Phase 3United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden
20EUCTR2010-018401-10-BE
(EUCTR)		23/11/201003/09/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes		1500Phase 3France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
21EUCTR2010-018401-10-FR
(EUCTR)		15/11/201027/07/2010A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant		Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes		1500Phase 3France;Belgium;Netherlands;Germany;Italy;United Kingdom
22EUCTR2010-019025-33-NL
(EUCTR)		31/08/201027/07/2010A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal FunctionA Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant		Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development Commercialization, Inc.NULLNot RecruitingFemale: yes
Male: yes		36Phase 2aNetherlands
23EUCTR2010-018401-10-DE
(EUCTR)		07/07/201010/06/2010A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys.A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]		Trade Name: Samsca 15 mg tablets
Product Name: Tolvaptan 15 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Trade Name: Samsca 30 mg tablets
Product Name: Tolvaptan 30 mg tablets
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan		Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes		1500France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom

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72. 下垂体性ADH分泌異常症　［臨床試験数：36，薬物数：22（DrugBank：5），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. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 36 trial found

225. 先天性腎性尿崩症　［臨床試験数：12，薬物数：45（DrugBank：17），標的遺伝子数：30，標的パスウェイ数：63］
Searched query = "Congenital nephrogenic diabetes insipidus", "Hereditary nephrogenic diabetes insipidus", "Nephrogenic diabetes insipidus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 12 trial found

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