- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264914
Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH Safety)
January 19, 2009 updated by: Sanofi
An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH.
Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Macquarie Park, Australia
- Sanofi-Aventis Administrative Office
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Diegem, Belgium
- Sanofi-Aventis Administrative Office
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Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
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Laval, Canada
- sanofi-aventis Canada
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Paris, France
- Sanofi-Aventis Administrative Office
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Berlin, Germany
- Sanofi-Aventis Administrative Office
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Causeway Bay, Hong Kong
- Sanofi-Aventis Administrative Office
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Budapest, Hungary
- Sanofi-Aventis Administrative Office
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Moscow, Russian Federation
- Sanofi-Aventis Administrative Office
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Geneva, Switzerland
- Sanofi-Aventis Administrative Office
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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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
Inclusion Criteria:
- Male or female patients aged 18 years and higher.
- SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, and normal renal, adrenal, and thyroid functions: drug induced SIADH will be limited to carbamazepine or derivatives and antidepressants in patients in whom these drugs cannot be discontinued or easily replaced by other drugs)
- Serum sodium between 115 and 132 mmol/L (at least two consecutive serum sodium levels of at least 24 hours apart, from Day -6 to Day -1); for sodium levels between 125 and 132 mmol/L, the spontaneous serum sodium increase between the two assessments on Day -1 should be < 4 mmol/L
- Urinary osmolality >200mOsm/kg H2O
- Urinary sodium > 30 mmol/L
Exclusion Criteria:
- Patients with acute postoperative SIADH
- Presence of dilutional hyponatremia in hypervolemic states such as congestive heart failure and liver disease with ascites
- Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit, …)
- Administration of other V2 receptor antagonists or demeclocycline or lithium within one month, thiazides diuretics or spironolactone within 15 days, and urea or loop diuretics within two days prior to study drug administration
- Patients with known treated or untreated adrenal deficiency
- Presence of untreated hypothyroidism
- Presence of uncontrolled diabetes with fasting glycemia > 200 mg/dL (> 11.09 mmol/L)
- Presence of clinical and/or electrocardiographical signs of acute myocardial infarction or acute ischemia, or any other clinically significant abnormality according to the Investigator on a 12 lead ECG recording
- Administration of inducers of CYP3A4 (phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitor so CYP3A4within two weeks prior to study drug administration
- Inadequate hematological, renal and hepatic functions; hemoglobin (Hb) < 9 g/dL, neutrophils < 1,500/mm3, platelets <100,00/mm3, serum creatine >175 µmol/L (or clearance of creatine <30mL/min for where Ethics Committees require this parameter), ALT and /or AST >2x upper limit of normal
- QTcB > 500 ms
- Serum potassium > 5 mmol/L
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
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Secondary Outcome Measures
Outcome Measure |
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Serum sodium
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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
July 1, 2005
Primary Completion (ACTUAL)
August 1, 2007
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
December 12, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (ESTIMATE)
December 13, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 19, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
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
- SFY5904
- LTS10208
- EudraCT : 2004-005239-35
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.
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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
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Western States Endurance Run Research FoundationUnknownExercise-associated HyponatremiaUnited States
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University Hospital, Basel, SwitzerlandRecruitingThiazide-induced Hyponatremia (TIH)Switzerland
Clinical Trials on SR121463B
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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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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
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SanofiCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionFrance, Germany, Belgium, Hungary
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SanofiCompletedLiver Cirrhosis | AscitesFrance, Germany, Italy, Spain, Taiwan, Belgium, Czech Republic, Argentina, Croatia, Canada, Australia
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SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, Canada, Brazil, Germany, Netherlands, Portugal, Spain, Belgium, Croatia, Hungary, Hong Kong
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SanofiCompletedCongestive Heart FailureUnited States, Canada, Poland, Romania, Portugal, Sweden, Belgium, Argentina, Denmark, Hungary, Israel, Australia, Chile, South Africa, Greece
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SanofiCompletedLiver Cirrhosis | AscitesUnited States, France, Romania, Germany, Italy, Spain, Belgium, Czech Republic, Argentina, Croatia, Hungary, Canada, Australia
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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
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SanofiCompletedLiver Cirrhosis | AscitesFrance, Romania, Germany, Spain, Belgium, Czech Republic, Argentina, Croatia, Hungary, Italy, Canada, Australia