Tolvaptan SIADH Study
- Conditions
- Syndrome of inappropriate secretion of antidiuretic hormones (SIADH)
- Registration Number
- JPRN-jRCT2080223457
- Lead Sponsor
- Otsuka Pharmaceutical Co., LTD.
- Brief Summary
Tolvaptan was suggested to be useful for patients with SIADH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Percentage of subjects with normalized serum sodium concentration<br>Percentage of subjects with normalized serum sodium concentration on the day after final IMP administration
- Secondary Outcome Measures
Name Time Method efficacy<br>Change in serum sodium concentration<br>Investigation on the change in serum sodium concentration<br><br>efficacy<br>Time course of serum sodium concentrations<br>Investigation on the time course of serum sodium concentrations<br><br>efficacy<br>Changes in clinical symptoms associated with hyponatremia<br>Assessment of clinical symptoms (anorexia, vomiting, headache, consciousness disturbance, and malaise) associated with hyponatremia