A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia

A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

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.

Inclusion Criteria:

• Participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia

Exclusion Criteria:

• Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor)
• Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension)
• Participants with adrenocortical insufficiency
• Participants with hypothyroidism
• Participants with known causes of transient SIADH
• Participants with psychogenic polydipsia or beer potomania
• Concomitant use of thiazide diuretics during the study
• Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening
• Participants with impaired hepatic function or liver cirrhosis (Child-Pugh A-C)
• Pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.