67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details


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

  
10 trials found
No.TrialIDDate_
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PhaseCountries
1NCT03406286
(ClinicalTrials.gov)
July 19, 201622/12/2017Samsca PMS in ADPKD PatientsPost-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKDSafetyDrug: TolvaptanKorea Otsuka Pharmaceutical Co., Ltd.NULLRecruiting18 YearsN/AAll600Korea, Republic of
2EUCTR2015-001903-30-DK
(EUCTR)
26/06/201513/05/2015Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney diseaseEffect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD Adult 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: Body processes [G] - Physical Phenomena [G01]
Trade Name: Samsca
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Denmark
3EUCTR2014-001973-15-DK
(EUCTR)
18/11/201427/06/2014The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney diseaseRenal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease
MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861
MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Trade Name: Samsca
Product Name: Tolvaptan
Product Code: C03XA01
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
University Clinic in Nephrology and Hypertension, Department of Medical ResearchNULLNot RecruitingFemale: yes
Male: yes
Denmark
4EUCTR2010-018401-10-NL
(EUCTR)
14/01/201121/10/2010A 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
Product Name: Tolvaptan
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
INN or Proposed INN: Tolvaptan
Otsuka Pharmaceutical Development & Commercialization, IncNULLNot RecruitingFemale: yes
Male: yes
1500France;United States;Canada;Poland;Belgium;Romania;Russian Federation;Afghanistan;Germany;Netherlands;Italy;United Kingdom
5EUCTR2010-018401-10-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
6EUCTR2010-018401-10-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
7EUCTR2010-018401-10-GB
(EUCTR)
05/10/201026/08/2010A 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 Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom
8EUCTR2010-019025-33-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 2Netherlands
9EUCTR2010-018401-10-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
10EUCTR2020-005992-10-DE
(EUCTR)
26/05/2021A trial to see if tolvaptan is safe in infants and children who at enrollment are 28 days to less than 18 years old with Autosomal Recessive Polycystic Kidney Disease (ARPKD)A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) Autosomal Recessive Polycystic Kidney Disease (ARPKD)
MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: SAMSCA 7.5 mg oral tablet
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 mg Tablet
Product Name: Tolvaptan 30 mg Tablet
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Product Name: Tolvaptan 50mg Granules
Product Code: OPC-41061
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN (OPC-41061)
Otsuka Pharmaceutical Development & Commercialization, Inc.NULLNAFemale: yes
Male: yes
10Phase 3United States;Belgium;Germany;United Kingdom;Italy