Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis MedDRA version: 7.1 Level: LLT Classification code 10021038
Conditions
Sponsors
Sanofi-Synthelabo Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged 18 years and higher • Dilutional hyponatremia with serum sodium between 115 and 132 mmol/L • Ability to give a written informed consent (the informed consent may 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 known treated or untreated adrenal insufficiency • Patients with known SIADH or cirrhosis • Presence of untreated hypothyroidism • QTcB = 500 ms • Presence of signs of hypovolemia • Administration of other V2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration • Presence of uncontrolled diabetes with fasting glycemia = 200 mg/dL (= 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia excluding known SIADH or cirrhosis. ;Secondary Objective: To assess the long-term efficacy of SR121463B in maintaining normonatremia in patients with dilutional hyponatremia excluding chronic SIADH or cirrhosis and to assess the safety and tolerability of SR121463B in these patients.;Primary end point(s): Serum sodium | — |
Countries
Denmark, Hungary, Sweden
Outcome results
None listed