Tolvaptan 30mg    (DrugBank: Tolvaptan)

1 disease
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16

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.
16 / 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
1EUCTR2014-001516-19-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
2EUCTR2014-001516-19-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
3EUCTR2014-001516-19-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
4EUCTR2014-001516-19-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
5EUCTR2014-000226-38-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
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-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
7EUCTR2014-000226-38-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
8EUCTR2014-000226-38-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
9EUCTR2014-000226-38-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
10EUCTR2014-000226-38-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
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-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
12EUCTR2014-001516-19-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
13EUCTR2014-000226-38-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
14EUCTR2014-000226-38-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
15EUCTR2014-000226-38-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
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-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