NCT02352285

Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure

Assessment of Clinical Outcome and Treatment Quality Under Adequate Use of Tolvaptan In Correction of Hyponatremia in Patients Hospitalized With Worsening Heart Failure and Hyponatremia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.

Detailed description

This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.

Conditions

• Heart Failure With Hyponatremia

Interventions

Type	Name	Description
DRUG	Tolvaptan	Start with 15mg to titrate upwards to 30mg to 60mg, once a daily
DRUG	Placebo	Start with 15mg to titrate upwards to 30mg to 60mg, once a daily

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-02-02
• Last updated: 2017-06-14

Locations

1 site across 1 country: South Korea