Opc-41061 (tolvaptan) (DrugBank: Tolvaptan)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 67 | Polycystic kidney disease | 1 |
| 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 | JPRN-JapicCTI-070402 | 25/1/2007 | 21/05/2007 | Tolvaptan efficacy and safety in management of polycystic kidney desease and its outcomes (TEMPO3/4) | A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan regimens in adult subjects with autosomal dominant polycystic kidney disease (ADPKD) | Autosomal dominant polycystic kidney disease (ADPKD) | Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 45/15 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 60/30 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 90/30 mg Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral | Otsuka Pharmaceutical Co., Ltd. | NULL | complete | 20 | 50 | BOTH | 1500 | Phase 3 | Japan, North America, South America, Europe, Oceania |