Clinical Trial: A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropria

Brief Summary: The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Percentage of subjects with normalized serum sodium concentration [ Time Frame: Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]

Percentage of subjects with normalized serum sodium concentration (≥ 135 mEq/L) on the day after final IMP administration


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in serum sodium concentration [ Time Frame: Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Change in serum sodium concentration
  • Time course of serum sodium concentrations [ Time Frame: Screening, Day -1, Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Time course of serum sodium concentrations
  • Changes in clinical symptoms associated with hyponatremia [ Time Frame: Screening, Day -1, Day 1, Day 3, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Changes in clinical symptoms associated with hyponatremia


Original Secondary Outcome: Same as current

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: February 7, 2017
Date Started: January 2017
Date Completion: March 2020
Last Updated: March 9, 2017
Last Verified: March 2017