- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264927
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
To assess the efficacy of SR121463B in correcting hyponatremia 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. To assess the safety and tolerability of SR121463B in patients with SIADH.
The double blind period is followed by an open label extension study with flexible doses of satavaptan.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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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 Administrative Office
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Zagreb, Croatia
- 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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Gouda, Netherlands
- Sanofi-Aventis Administrative Office
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Porto Salvo, Portugal
- Sanofi-Aventis Administrative Office
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Barcelona, Spain
- 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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 nay 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, ALT and /or AST >2x upper limit of normal
- QTcB > 500 ms
- Serum potassium > 5 mmol/L
Study Plan
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 |
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Serum sodium
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Secondary Outcome Measures
Outcome Measure |
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Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
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Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- EFC4489
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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University Hospital, Basel, SwitzerlandNot yet recruitingThiazide Associated HyponatremiaSwitzerland
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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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Western States Endurance Run Research FoundationUnknownExercise-associated HyponatremiaUnited States
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University of CologneRecruitingNon-hypervolemic HyponatremiaGermany
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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SanofiCompletedHyponatremia | Inappropriate ADH SyndromeUnited States, France, Brazil, Russian Federation, Australia, Germany, Switzerland, Belgium, Hungary, Hong Kong, Canada
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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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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