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

Phase 3

Terminated

• Conditions: Hyponatremia; Inappropriate ADH Syndrome
• Interventions: Drug: Satavaptan; Drug: placebo

• Registration Number: NCT00728091
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-26
• Disposition First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Disposition First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Satavaptan Dose 1	Satavaptan	Fixed Low dose up to day 4, followed by optional titration up to day 30
Satavaptan Dose 2	Satavaptan	Fixed High dose up to day 4, followed by optional titration up to day 30
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
serum sodium change from baseline	At Day 5 pre-dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States