Otsuka Holdings Co., Ltd.: Hyponatremia trials

The registry lists 18 Hyponatremia studies with Otsuka Holdings Co., Ltd. as lead sponsor. 0 are open to participants now and 9 have results posted.

Phase 2 1Phase 3 9Phase 4 2No phase 6(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADHCompletedNCT03048747Phase 3Results posted
• Samsca Post Marketing Surveillance StudyCompletedNCT02722863Results posted
• An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in SpainCompletedNCT02548845Results posted
• An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADHCompletedNCT02545101Results posted
• International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic HyponatremiaCompletedNCT02449044Phase 3Results posted
• An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic HyponatremiaTerminatedNCT02020278Phase 3Results posted
• Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic HyponatremiaTerminatedNCT02012959Phase 3Results posted
• Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional HyponatremiaTerminatedNCT01227512Phase 3Results posted
• Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic PatientsCompletedNCT00550459Phase 3Results posted
• An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in ItalyCompletedNCT02573077
• A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic HyponatremiaWithdrawnNCT02442674Phase 3
• Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart FailureTerminatedNCT02352285Phase 4
• Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With AscitesTerminatedNCT01552590Phase 4
• Hyponatremia Registry for Patients With Euvolemic and Hypervolemic HyponatremiaCompletedNCT01240668
• Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical PracticeStatus unknownNCT01228682
• A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute HyponatremiaCompletedNCT00664014Phase 2
• Study of Ascending Levels of Tolvaptan in HyponatremiaCompletedNCT00201994Phase 3
• "SALT Trial" Study of Ascending Levels of Tolvaptan in HyponatremiaCompletedNCT00072683Phase 3