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.

sanofi-aventis recherche et développement0 个研究点目标入组 68 人开始时间: 2007年4月23日最近更新: 2012年3月19日

试验速览

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•- 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
•*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.

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