Clinical Trial: DILIPO (DILutIonal HyPOnatremia)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients Wit
Brief Summary:
Primary:
- To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis
Secondary:
- To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients
- To assess the safety and tolerability of SR121463B
Detailed Summary: SR121463B is an orally effective non-peptide, potent, and highly selective V2 receptor antagonist causing free water elimination in animals and humans
Sponsor: Sanofi
Current Primary Outcome:
- EFFICACY:Serum Sodium
- SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
- PHARMACOKINETICS:Plasma SR121463B concentrations
Original Primary Outcome: Same as current
Current Secondary Outcome: Weight; EQ-5D and pharmaco-economic assessments
Original Secondary Outcome: Weight; EQ-5D and pharmaco-economic assessements
Information By: Sanofi
Dates:
Date Received: January 9, 2006
Date Started: May 2005
Date Completion:
Last Updated: September 12, 2008
Last Verified: September 2008