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

NCT02352285 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-06-14

No results posted yet for this study

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.

Conditions

  • Heart Failure With Hyponatremia

Interventions

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

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongju Choi, MD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352285 on ClinicalTrials.gov