Otsuka Holdings Co., Ltd.: Heart Failure trials

The registry lists 21 Heart Failure studies with Otsuka Holdings Co., Ltd. as lead sponsor. 0 are open to participants now and 11 have results posted.

Phase 1 1Phase 2 6Phase 3 9Phase 4 2No phase 3(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 Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])CompletedNCT05615363Phase 2Results posted
• Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral IntakeCompletedNCT03962101Phase 3Results posted
• Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureCompletedNCT03772041Phase 3Results posted
• Phase I Study of OPC-61815CompletedNCT03510663Phase 1Results posted
• Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume OverloadCompletedNCT03255226Phase 3Results posted
• Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureCompletedNCT03254108Not applicableResults posted
• Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure PatientsCompletedNCT01439009Phase 4Results posted
• A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)CompletedNCT00544869Phase 3Results posted
• A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)CompletedNCT00525265Phase 3Results posted
• A Double-blind, Placebo-controlled Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure)CompletedNCT00462670Phase 3Results posted
• A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)CompletedNCT00234104Phase 2Results posted
• A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart FailureWithdrawnNCT06795399Phase 2
• Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.Active, not recruitingNCT05712746
• Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart FailureCompletedNCT04719637Not applicable
• Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart FailureTerminatedNCT02352285Phase 4
• Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart FailureCompletedNCT01618448Phase 3
• Study of Ascending Levels of Tolvaptan in HyponatremiaCompletedNCT00201994Phase 3
• Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart FailureCompletedNCT00132886Phase 2
• EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With TolvaptanCompletedNCT00071331Phase 3
• Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure PatientsCompletedNCT00043771Phase 2
• Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure PatientsCompletedNCT00043758Phase 2