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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion

Treatments: Drug: Tolvaptan Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03048747

156-14-003

JapicCTI-173512 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Tolvaptan

Experimental group

Description:

Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.

Treatment:

Drug: Tolvaptan Oral Tablet