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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03048747
• Date of registration: 07/02/2017
• Prospective Registration: Yes
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public title: A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
• Scientific 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 Inappropriate Antidiuretic Hormone Secretion (SIADH)
• Date of first enrolment: March 2, 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03048747
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment
Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"

- Subjects who have been on fluid restriction for at least 7 consecutive days at the
time of informed consent and who are showing no improvement of hyponatremia at the
time of the screening examination

Exclusion Criteria:

- Subjects who have transient hyponatremia induced by drug administration

- Subjects who are unable to sense thirst or who have difficulty with fluid intake

- Subjects with urinary tract obstruction

- Subjects who have participated in any other clinical trial within 30 days prior to
informed consent

- Subjects with serum sodium concentration of <120 mEq/L associated with neurologic
impairment, including apathy, confusion, or seizures



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Syndrome of Inappropriate Antidiuretic Hormone Secretion

Intervention(s)

Drug: Tolvaptan Oral Tablet

Primary Outcome(s)

Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration [Time Frame: Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication]

Secondary Outcome(s)

Change in Serum Sodium Concentration [Time Frame: Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration]

Secondary ID(s)

156-14-003

JapicCTI-173512

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03048747