An open-label, multicenter study evaluating the long-term safety of satavaptan (SR121463B) and maintenance of normonatremia in patients with dilutional hyponatremia who have previously been treated in studies LTS5066, EFC4489 or SFY5904.
- Conditions
- Dilutional hyponatremiaMedDRA version: 9.1Level: LLTClassification code 10021036Term: Hyponatraemia
- Registration Number
- EUCTR2006-005422-23-HU
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
- 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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method