Syndrome of inappropriate secretion of antidiuretic hormones (SIADH)
Conditions
Interventions
investigational material(s)
Generic name etc : Tolvaptan
INN of investigational material : -
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material : Tolvapta
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
All
Inclusion 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
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 below 120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of subjects with normalized serum sodium concentration Percentage of subjects with normalized serum sodium concentration on the day after final IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change in serum sodium concentration Investigation on the change in serum sodium concentration efficacy Time course of serum sodium concentrations Investigation on the time course of serum sodium concentrations efficacy Changes in clinical symptoms associated with hyponatremia Assessment of clinical symptoms (anorexia, vomiting, headache, consciousness disturbance, and malaise) associated with hyponatremia | — |
Countries
Japan
Outcome results
None listed