Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders.

• Conditions: Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH); MedDRA version: 14.1Level: SOCClassification code 10014698Term: Endocrine disordersSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-004071-39-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- age >18
- admission to Neurosurgery Unit for pituitary surgery
- Serum sodium levels lower than 135 mEq/l and higher than 120 mEq/l
- One or more symptoms of hyponatremia
- Euvolemic patient
- Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Anuria
- Impaired renal function(grade IV KDOQI)
- Liver failure
- Hypovolemia
- Hyponatremic hypovolemia
- Lack of sense to thirst
- Cotreatment with inhibitors/inductors of CYP3A4
- Pregnancy
- Brestfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified