A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia (AQUARIST1)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Inappropriate ADH Syndrome; Hyponatremia

Treatments: Drug: placebo; Drug: Satavaptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728091

EudraCT:2007-007941-10

EFC10102

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 3 patient groups, including a placebo group

Satavaptan Dose 1

Experimental group

Description:

Fixed Low dose up to day 4, followed by optional titration up to day 30

Treatment:

Drug: Satavaptan

Satavaptan Dose 2

Experimental group

Description:

Fixed High dose up to day 4, followed by optional titration up to day 30

Treatment:

Drug: Satavaptan

Placebo

Placebo Comparator group

Treatment:

Drug: placebo