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

Primary Purpose

Hyponatremia, Inappropriate ADH Syndrome

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Satavaptan

placebo

About this trial

This is an interventional treatment trial for Hyponatremia focused on measuring aquaretic, SIADH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Satavaptan Dose 1

Satavaptan Dose 2

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum sodium change from baseline

Secondary Outcome Measures

responder rate

presence and intensity of clinical symptoms related to hyponatremia

change from baseline in cognitive function

Full Information

NCT ID

NCT00728091

First Posted

July 31, 2008

Last Updated

April 26, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00728091

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyponatremia, Inappropriate ADH Syndrome

Keywords

aquaretic, SIADH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Satavaptan Dose 1

Arm Type

Experimental

Arm Description

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

Arm Title

Satavaptan Dose 2

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Satavaptan

Other Intervention Name(s)

SR121463

Intervention Description

tablets

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

tablets

Primary Outcome Measure Information:

Title

serum sodium change from baseline

Time Frame

At Day 5 pre-dose

Secondary Outcome Measure Information:

Title

responder rate

Time Frame

At Day 5 pre-dose

Title

presence and intensity of clinical symptoms related to hyponatremia

Time Frame

At each scheduled visit

Title

change from baseline in cognitive function

Time Frame

At Day 5 and 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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