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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hyponatremia, Inappropriate ADH Syndrome

Intervention / Treatment
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* Drug: Satavaptan
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Satavaptan Dose 1<br>Fixed Low dose up to day 4, followed by optional titration up to day 30 | Drug: Satavaptan<br>* tablets<br>* Other names: SR121463;|
| Experimental: Satavaptan Dose 2<br>Fixed High dose up to day 4, followed by optional titration up to day 30 | Drug: Satavaptan<br>* tablets<br>* Other names: SR121463;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sodium change from baseline |  | At Day 5 pre-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responder rate |  | At Day 5 pre-dose | 
| presence and intensity of clinical symptoms related to hyponatremia |  | At each scheduled visit | 
| change from baseline in cognitive function |  | At Day 5 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aquaretic, SIADH