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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00728091

Acronym

AQUARIST1

Enrollment

Registered

2008-08-05

Start date

2008-07-31

Completion date

2008-12-31

Last updated

2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, Inappropriate ADH Syndrome

Keywords

aquaretic, SIADH

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.

Interventions

DRUGSatavaptan

tablets

DRUGplacebo

tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
serum sodium change from baseline	At Day 5 pre-dose

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026