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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00264914
Registration number
NCT00264914
Ethics application status
Date submitted
12/12/2005
Date registered
13/12/2005
Date last updated
21/01/2009
Titles & IDs
Public title
Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
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Scientific title
An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
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Secondary ID [1]
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LTS10208
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Secondary ID [2]
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SFY5904
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Universal Trial Number (UTN)
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Trial acronym
SIADH Safety
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inappropriate ADH Syndrome
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Hyponatremia
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Metabolic and Endocrine
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Diabetes
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SR121463B
Treatment: Drugs: SR121463B
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Serum sodium
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2007
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
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United States of America
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New Jersey
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Belgium
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Diegem
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Brazil
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Sao Paulo
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Canada
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Laval
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France
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Paris
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Germany
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Berlin
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Hong Kong
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Causeway Bay
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Hungary
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Budapest
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Russian Federation
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Moscow
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Switzerland
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State/province [10]
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Geneva
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00264914
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ICD CSD
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00264914
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