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Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

NCT ID: NCT00032734

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2003-07-31

Brief Summary

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The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

Detailed Description

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This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Conditions

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Syndrome of Inappropriate ADH (SIADH) Secretion Hyponatremia

Keywords

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Low Blood Sodium (Hyponatremia) SIADH Inappropriate ADH Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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satavaptan (SR121463B)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

SIADH of any origin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-aventis Administrative Office

Paris, , France

Site Status

Sanofi-aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-aventis Administrative Office

Budapest, , Hungary

Site Status

Countries

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Canada United States Belgium France Germany Hungary

Related Links

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http://www.centerwatch.com

Related Info

http://www.sanofi-aventis.com

Related Info

Other Identifiers

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SR121463

Identifier Type: -

Identifier Source: secondary_id

LTS5066

Identifier Type: -

Identifier Source: secondary_id

LTS10208

Identifier Type: -

Identifier Source: secondary_id

DFI4488

Identifier Type: -

Identifier Source: org_study_id