A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia
- Conditions
- Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosisMedDRA version: 7.1Level: LLTClassification code 10021038
- Registration Number
- EUCTR2004-003985-14-DK
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
• Male or female patients aged 18 years and higher
• Dilutional hyponatremia with serum sodium between 115 and 132 mmol/L
• Ability to give a written informed consent (the informed consent may 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 known SIADH or cirrhosis
• Presence of signs of hypovolemia
• Administration of other V2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration
• Presence of untreated hypothyroidism or adrenal deficiency
• Presence of uncontrolled diabetes with fasting glycemia = 200 mg/dL (= 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
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 efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia excluding known SIADH or cirrhosis.<br>;Secondary Objective: To assess the long-term efficacy of SR121463B in maintaining normonatremia in patients with dilutional hyponatremia excluding known SIADH or cirrhosis and to assess the safety and tolerability of SR121463B in these patients.;Primary end point(s): Serum sodium
- Secondary Outcome Measures
Name Time Method