67. Polycystic kidney disease Clinical trials / Disease details
Clinical trials : 216 / Drugs : 219 - (DrugBank : 50) / Drug target genes : 39 - Drug target pathways : 151
| 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 | EUCTR2017-004115-39-DK (EUCTR) | 08/02/2018 | 13/12/2017 | Same as above | Subacute 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 Endocrinology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 4 | Denmark | ||
| 2 | EUCTR2020-005992-10-DE (EUCTR) | 26/05/2021 | A 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. | NULL | NA | Female: yes Male: yes | 10 | Phase 3 | United States;Belgium;Germany;United Kingdom;Italy |