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 - DILIPO

Phase 1

• Conditions: Dilutional hyponatremia excluding known syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis; MedDRA version: 7.1Level: LLTClassification code 10021038

• Registration Number: EUCTR2004-003985-14-BE
• Lead Sponsor: Sanofi-Synthelabo Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-20
• Study Completion: 2007-07-18
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with known treated or untreated adrenal insufficiency
• 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
• 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
• QTcB >= 500 ms

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