DILIPO (DILutIonal HyPOnatremia)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00274326
• Date of registration: 09/01/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: DILIPO (DILutIonal HyPOnatremia)
• Scientific title: 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
• Date of first enrolment: May 2005
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00274326
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, Denmark, Greece, Hungary, Israel, Poland, Portugal, Romania, South Africa, Sweden, United States

Contacts

• Name: Daniel Ter-Minassian, MD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Congestive Heart Failure

Intervention(s)

Drug: SR121463B

Primary Outcome(s)

PHARMACOKINETICS:Plasma SR121463B concentrations

EFFICACY:Serum Sodium

SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry

Secondary Outcome(s)

Weight; EQ-5D and pharmaco-economic assessments

Secondary ID(s)

EFC5816

Source(s) of Monetary Support

Please refer to primary and secondary sponsors