An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety
- Conditions
- Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L.MedDRA version: 7.1Level: LLTClassification code 10040626
- Registration Number
- EUCTR2004-005239-25-DE
- Lead Sponsor
- Sanofi-Synthelabo Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
• Male or female patients aged 18 years and higher
• SIADH
• Serum sodium between 115 mmol/L and 132 mmol/L
• Urinary osmolality > 200 mOsm/kg H2O
• Urinary sodium > 30 mmol/L
• Ability to give written informed consent (the informed consent form should be signed by a legally authorized representative if the patient is unable to sign).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Patients with acute post operative SIADH
• Presence of dilutional hyponatremia in hypervolemic states (CHF and liver disease with Ascites)
• Presence of sign of hypovolemia
• Administration of other V2 receptor antogonists or demeclocycline or lithium within one month, thiazide diuretics or spironolactone within 15 days and urea or loop diuretics within 2 days prior to study drug administration.
• Presence of known treated or untreated adrenal deficiency
• Presence of untreated hypothyroidism
• Presence of uncontrolled diabetes with fasting glycemia > or equal to 200 mg/dL (> or equal 11.09 mmol/L)
• Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John’s Wort) or potent and specific moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
• Inadequate hematological, renal and hepatic functions
Positive pregnancy test and absence of medically approved contraceptive methods for female of childbearing potential
• Pregnancy or breast-feading
• Administration of inducers of CYP 3A4 (phenobarbital, phenytoin, rifampicine, Saint John's Wort) or potent or specific moderate inhibitors of CYP3A4. within 2 weeks prior to study drug administration
• QTcB = 500 ms
• Serum potassium > 5 mmol/L
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the long term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH).;Secondary Objective: to assess the long term efficacy of SR121463B in maintaining normonatremia in patients with SIADH.;Primary end point(s): Serum sodium
- Secondary Outcome Measures
Name Time Method