Primary: * To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis Secondary: * To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients * To assess the safety and tolerability of SR121463B
SR121463B is an orally effective non-peptide, potent, and highly selective V2 receptor antagonist causing free water elimination in animals and humans
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
sanofi-aventis Australia & New Zealand administrative office
EFFICACY:Serum Sodium
SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
PHARMACOKINETICS:Plasma SR121463B concentrations
Weight; EQ-5D and pharmaco-economic assessments
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Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
Sanofi-Aventis Administrative Office
Athens, Greece
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Netanya, Israel
...and 5 more locations