SAMSCA 7.5 mg oral tablet ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 67 | Polycystic kidney disease | 1 |
67. Polycystic kidney disease
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 | 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 |