Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L. MedDRA version: 7.1 Level: LLT Classification code 10040626
Conditions
Sponsors
Sanofi-Synthelabo Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged 18 years and higher • SIADH • Serum sodium between 115 mmol/L and 132 mmol/L • Urinary osmolality > 200 mOsm/kg H2O • Urinary sodium > 30 mmol/L • Ability to give written informed consent (the informed consent form should be signed by a legally authorized representative if the patient is unable to sign). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with acute post operative SIADH • Presence of dilutional hyponatremia in hypervolemic states (CHF and liver disease with Ascites) • Presence of sign of hypovolemia • Administration of other V2 receptor antogonists or demeclocycline or lithium within one month, thiazide diuretics or spironolactone within 15 days and urea or loop diuretics within 2 days prior to study drug administration. • Presence of known treated or untreated adrenal deficiency • Presence of untreated hypothyroidism • Presence of uncontrolled diabetes with fasting glycemia > or equal to 200 mg/dL (> or equal 11.09 mmol/L) • Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John’s Wort) or potent and specific moderate inhibitors of CYP3A4 within two weeks prior to study drug administration • Inadequate hematological, renal and hepatic functions Positive pregnancy test and absence of medically approved contraceptive methods for female of childbearing potential • Pregnancy or breast-feading • Administration of inducers of CYP 3A4 (phenobarbital, phenytoin, rifampicine, Saint John's Wort) or potent or specific moderate inhibitors of CYP3A4. within 2 weeks prior to study drug administration • QTcB = 500 ms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the long term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH).;Secondary Objective: to assess the long term efficacy of SR121463B in maintaining normonatremia in patients with SIADH.;Primary end point(s): Serum sodium | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed