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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hyponatremia, Inappropriate ADH Syndrome

In brief

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.

Key facts

Study ID

NCT00728091

Run by

Sanofi

People needed

2

Starts

2008-07-01

Expected to finish

2008-12-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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