drugset / Trial / NCT01651156

Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema

NCT01651156

Phase 3 Completed 244 enrolled Otsuka Beijing Research Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid retention caused by congestive heart failure) based on the conventional therapy. To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients with body fluid retention after current diuretic treatment, after continuous treatment of 7 days' oral Tolvaptan 15mg or placebo.

Timeline

Start
2012-07
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral