Dilutional hyponatremia MedDRA version: 9.1 Level: LLT Classification code 10021036 Term: Hyponatraemia
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who completed a minimum of one year treatment with satavaptan in studies EFC4489, LTS5066 or SFY5904 and - Who have no treatment discontinuation >4 days between discontinuation of the previous study and entering this study. 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: -Refusal or inability to give informed consent to participate in the study -Serum potassium <3.5 mmol/L or =5.0 mmol/L -Serum magnesium below the lower limit of the local laboratory normal range -Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit) -Presence of signs of acute myocardial infarction or ischemia, or any other clinically significant abnormality according to the Investigator on electrocardiogram (ECG) recording (12-lead ECG) -QTcF =480ms -Concomitant use of other vasopressin V2 receptor antagonist -Concomitant use of potent and selected moderate inhibitors of CYP 3A4 enzymes -Presence of history of allergic reaction to SR1214163B or compounds with similar chemical structure -Pregnant or breast-feeding women -Women of child-bearing potential are excluded unless they meet one of the following criteria: *Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test *Surgical sterilization for more than one month duration and a negative pregnancy test *Use of contraceptive intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test *Use of oral contraceptive in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of satavaptan in patients with dilutional hyponatremia.;Secondary Objective: To monitor the long-term maintenance of normonatremia in patients with dilutional hyponatremia treated with satavaptan.;Primary end point(s): There is no primary endpoint in this study as it is a non-confirmatory, descriptive study. | — |
Countries
Belgium, Germany, Hungary
Outcome results
None listed