Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

Summary

The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.

Conditions

• Hyponatremia
• Ascites

Interventions

DRUG

Tolvaptan

15 - 60 mg/day for 28 days

DRUG

placebo

Sponsors & Collaborators

• Inje University

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Incheon St.Mary's Hospital

  collaborator OTHER

• Chungnam National University

  collaborator OTHER

• Konkuk University Medical Center

  lead OTHER

Principal Investigators

• June Sung Lee, MD, PhD · Inje University Ilsan Paik Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2014-01-31

Completion

2014-02-28

Countries

• South Korea

Study Locations