Inappropriate ADH SyndromePhase 3SIADHNCT00264927
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
A Phase 3 study testing SR121463B in people with Inappropriate ADH Syndrome and Hyponatremia, run by Sanofi at 11 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inappropriate ADH Syndrome, Hyponatremia
- What is being tested?
- SR121463B
- How many people
- 77 participants
- Where
- 11 sitesin 11 countries
- Study dates
- May 2004to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: 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.
- Conditions
- Inappropriate ADH Syndrome, Hyponatremia
- Being tested
- SR121463B
- Keywords
- Inappropriate ADH Syndrome, Hyponatremia
- Medical subject headings
- Inappropriate ADH Syndrome, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR121463BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sodium
Secondary outcomes (2)
Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startMay 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate ADH SyndromeStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264927
- Sponsor's protocol ID
- EFC4489
- Acronym
- SIADH
- Status last verified
- Dec 2008
- First submitted
- 12 Dec 2005
- Last updated
- 10 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
- ClinicalTrials.gov ID
- NCT00264927
- Acronym / sponsor ID
- SIADH / EFC4489
- Conditions
- Inappropriate ADH Syndrome, Hyponatremia
- Keywords
- Inappropriate ADH Syndrome, Hyponatremia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 13 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR121463B | Drug | – |
Primary outcome
Serum sodium
2 secondary outcomes
Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2008.
- Related InfoLink provided by the sponsor.
Related trials for Inappropriate ADH Syndrome
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SIAD - Syndrome of Inappropriate Antidiuresis
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Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
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Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR121463B in people with Inappropriate ADH Syndrome and Hyponatremia, run by Sanofi at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, Brazil, Canada, Croatia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sodium. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2008.