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

  
4 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04782258
(ClinicalTrials.gov)
July 15, 202219/2/2021A Study 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 (ARPKD)Drug: Tolvaptan Suspension;Drug: Tolvaptan TabletsOtsuka Pharmaceutical Development & Commercialization, Inc.NULLRecruiting28 Days18 YearsAll10Phase 3United States;Belgium;France;Germany;Italy;Poland;United Kingdom
2EUCTR2017-004115-39-DK
(EUCTR)
08/02/201813/12/2017Same as aboveSubacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney DIsease
MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 15 or 45 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 60 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Trade Name: Jinarc 30 mg tablets, 90 mg tablets
Product Name: Jinarc - Tolvaptan tablets
Product Code: 30 or 90 mg
INN or Proposed INN: Tolvaptan
Other descriptive name: TOLVAPTAN
Nordsjællands Hospital, Department of Cardiology, Nephrology and EndocrinologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 4Denmark
3NCT00428948
(ClinicalTrials.gov)
January 200726/1/2007Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney Disease, Autosomal DominantDrug: Tolvaptan;Drug: PlaceboOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 Years50 YearsAll1445Phase 3United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom
4NCT00413777
(ClinicalTrials.gov)
December 200518/12/2006Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney, Autosomal DominantDrug: TolvaptanOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka Pharmaceutical Co., Ltd.Completed18 YearsN/AAll46Phase 2United States