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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.

Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004071-39-IT
Enrollment
Unknown
Registered
2012-10-31
Start date
2012-10-16
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: SAMSCA*10CPR 15MG Pharmaceutical Form: Tablet INN or Proposed INN: TOLVAPTAN CAS Number: 150683-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-

Sponsors

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of effectiveness and safety of Tolvaptan in the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.;Secondary Objective: Evaluation of mean resolution time of hyponatremia in the two groups of treatment (tolvaptan vs fluid resctriction).;Primary end point(s): Normalization of serum sodium levels in patients affected by sindrome of inappropriate secretion of antidiuretic hormone;Timepoint(s) of evaluation of this end point: Between 1 and 10 days—

Secondary

MeasureTime frame
Timepoint(s) of evaluation of this end point: Between 1 and 10 days;Secondary end point(s): Reduction of mean resolution time of hyponatremia in patients reated with Tolvaptan in respect to patients treated with fluid restriction—

Countries

Italy

Contacts

Public ContactU.O. ENDOCRINOLOGIA

FONDAZIONE IRCCS CA'GRANDA OSPEDALE MAGGIORE POLICLINICO

paolo.beckpeccoz@unimi.it02.55033356

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026