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

Hyponatremia Clinical Trial

— AQUARIST1  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00728091
• Other study ID #: EFC10102
• Secondary ID: EudraCT:2007-007
• Status: Terminated
• Phase: Phase 3
• First received: July 31, 2008
• Last updated: March 16, 2009
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of satavaptan versus placebo in patients 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 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 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)

• Patients with adrenocortical insufficiency

• Patients with hypothyroidism

• Patients with known causes of transient SIADH

• Patients 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

• Patients 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 patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia
• Inappropriate ADH Syndrome

Intervention

Drug:
• satavaptan (SR121463)
tablets
• satavaptan (SR121463)
tablets
• placebo
tablets

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum sodium change from baseline		At Day 5 pre-dose	No
Secondary	responder rate		At Day 5 pre-dose	No
Secondary	presence and intensity of clinical symptoms related to hyponatremia		At each scheduled visit	No
Secondary	change from baseline in cognitive function		At Day 5 and 30	No