The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH. Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
tablets
tablets
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
serum sodium change from baseline
Time frame: At Day 5 pre-dose
responder rate
Time frame: At Day 5 pre-dose
presence and intensity of clinical symptoms related to hyponatremia
Time frame: At each scheduled visit
change from baseline in cognitive function
Time frame: At Day 5 and 30
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