A Phase III Study Evaluating the Efficacy and Safety of S... | NCT00728091

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

NCT00728091

Sponsor

Sanofi

Status

Terminated

Last Update Posted

May 26, 2016Estimated

Enrollment

2Actual

Phase

Phase 3

Conditions

Hyponatremia
Inappropriate ADH Syndrome

Interventions

Satavaptan
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT:2007-007941-10

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 4, 2008

First Posted Date

Aug 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 26, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 26, 2016

Certification/Extension First Posted Date

May 26, 2016Estimated

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

May 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Satavaptan Dose 1	Experimental	Fixed Low dose up to day 4, followed by optional titration up to day 30	Drug: Satavaptan
Satavaptan Dose 2	Experimental	Fixed High dose up to day 4, followed by optional titration up to day 30	Drug: Satavaptan
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Satavaptan	Drug	tablets	Satavaptan Dose 1 Satavaptan Dose 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States

Condition Browse Module

MeSH Terms

ID	Term
D007010	Hyponatremia
D007177	Inappropriate ADH Syndrome

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010900	Pituitary Diseases

Browse Leaves

Not provided

Browse Branches

Not provided