- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032734
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
June 16, 2008 updated by: Sanofi
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
SIADH of any origin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
serum sodium concentration
|
Secondary Outcome Measures
Outcome Measure |
---|
safety assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
March 29, 2002
First Submitted That Met QC Criteria
March 29, 2002
First Posted (Estimate)
April 1, 2002
Study Record Updates
Last Update Posted (Estimate)
June 17, 2008
Last Update Submitted That Met QC Criteria
June 16, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease
- Hypothalamic Diseases
- Pituitary Diseases
- Water-Electrolyte Imbalance
- Syndrome
- Hyponatremia
- Diabetes Insipidus
- Inappropriate ADH Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Antidiuretic Hormone Receptor Antagonists
- Satavaptan
Other Study ID Numbers
- DFI4488
- SR121463
- LTS5066
- LTS10208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyponatremia
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Otsuka Frankfurt Research Institute GmbHUnknownSIADH | Non-SIADH Hyponatremia | Non-HyponatremiaDenmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom
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Otsuka America PharmaceuticalRegistrat-MapiCompletedEuvolemic Hyponatremia | Hypervolemic HyponatremiaUnited States, United Kingdom, Germany
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Korea Otsuka Pharmaceutical Co., Ltd.CompletedHypervolemic and Euvolemic HyponatremiaKorea, Republic of
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Hospital Italiano de Buenos AiresSociedad Argentina de Hipertension Arterial (SAHA)CompletedThiazide Diuretics Induced HyponatremiaArgentina
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CardioKine Inc.Biogen; Cardiokine Biopharma, LLCCompletedEuvolemic HyponatremiaUnited States, Israel, India, Mexico, Peru, Belgium, Czech Republic, Italy
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CardioKine Inc.Biogen; Cardiokine Biopharma, LLCCompletedHyponatremia With Excess Extracellular Fluid Volume | Hyponatremia With Normal Extracellular Fluid VolumeUnited States
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Jiangsu HengRui Medicine Co., Ltd.Beijing Friendship Hospital; Beijing 302 Hospital; Beijing Anzhen HospitalUnknownNon-hypovolemic Non-acute HyponatremiaChina
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University of CologneRecruitingNon-hypervolemic HyponatremiaGermany
-
Western States Endurance Run Research FoundationUnknownExercise-associated HyponatremiaUnited States
-
University Hospital, Basel, SwitzerlandRecruitingThiazide-induced Hyponatremia (TIH)Switzerland
Clinical Trials on satavaptan (SR121463B)
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SanofiCompletedLiver Cirrhosis | AscitesFrance, Germany, Italy, Spain, Taiwan, Belgium, Czech Republic, Argentina, Croatia, Canada, Australia
-
SanofiCompletedLiver Cirrhosis | AscitesUnited States, France, Romania, Germany, Italy, Spain, Belgium, Czech Republic, Argentina, Croatia, Hungary, Canada, Australia
-
SanofiCompletedLiver Cirrhosis | AscitesFrance, Romania, Germany, Spain, Belgium, Czech Republic, Argentina, Croatia, Hungary, Italy, Canada, Australia
-
SanofiTerminatedLiver Cirrhosis | AscitesFrance, Canada, Romania, Australia, Germany, Italy, Portugal, Spain, Bulgaria, Malaysia, Serbia, Singapore, Taiwan, Belgium, Czech Republic, Croatia, Hungary, Israel, United Kingdom, Korea, Republic of, South Africa, United States, ... and more
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SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, France, Brazil, Russian Federation, Australia, Germany, Switzerland, Belgium, Hungary, Hong Kong, Canada
-
SanofiCompletedLiver Cirrhosis | AscitesUnited States, France, Brazil, Poland, Romania, Russian Federation, Italy, Netherlands, Portugal, Sweden, Belgium, Argentina, Croatia, Denmark, Hungary, Israel, Spain, Chile, Canada, United Kingdom, Australia
-
SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, Canada, Brazil, Germany, Netherlands, Portugal, Spain, Belgium, Croatia, Hungary, Hong Kong
-
SanofiCompletedCongestive Heart FailureUnited States, Canada, Poland, Romania, Portugal, Sweden, Belgium, Argentina, Denmark, Hungary, Israel, Australia, Chile, South Africa, Greece
-
SanofiTerminatedLiver Cirrhosis | AscitesFrance, Canada, Brazil, Poland, Romania, Russian Federation, Australia, Germany, Spain, Turkey, Bulgaria, Malaysia, Serbia, Singapore, Belgium, Czech Republic, Mexico, Chile, United States, Argentina, Bosnia and Herzegovina
-
SanofiTerminatedHyponatremia | Inappropriate ADH SyndromeUnited States