DILIPO (DILutIonal HyPOnatremia)

Phase 3

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00274326
• Lead Sponsor: Sanofi

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 Description

SR121463B is an orally effective non-peptide, potent, and highly selective V2 receptor antagonist causing free water elimination in animals and humans

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-12
• Last Update Posted: 2008-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Male or Female patients aged 18 higher
• Dilutional Hyponatremia with serum sodium between 115 and 132 mmol/L
• Ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)

Exclusion Criteria

• Presence of known or untreated adrenal insufficiency, SIADH or cirrhosis, or hyperthyroidism
• 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 uncontrolled diabetes with fasting glycemia ³ 200 mg/dL (³ 11.09 mmol/L)
• Patients considered by the Investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the Investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious)
• Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
• Presence or history of allergic reaction to SR121463B8
• Previous study with SR121463B
• Inadequate hematological, renal, and hepatic functions: hemoglobin (Hb) < 9 g/dL, neutrophils < 1,500/mm3, platelets < 100,000/mm3, serum creatinine > 175 mol/L (or clearance of creatinine < 30 mL/min for sites where Ethics Committees require this parameter), serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN)
• QTCB 500 ³ ms
• Positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential
• Pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PHARMACOKINETICS:Plasma SR121463B concentrations
EFFICACY:Serum Sodium
SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry

Secondary Outcome Measures

Name	Time	Method
Weight; EQ-5D and pharmaco-economic assessments

Trial Locations

Locations (2)

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden

sanofi-aventis Australia & New Zealand administrative office; 🇦🇺 Macquarie Park, New South Wales, Australia