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DILIPO (DILutIonal HyPOnatremia) | Clinical Trials | Clareo Health

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DILIPO (DILutIonal HyPOnatremia)

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

NCT00274326•Sanofi

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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
+2 more criteria

Locations (15)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Diegem, Belgium

Sanofi-Aventis Administrative Office

Laval, Canada

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Hørsholm, Denmark

Sanofi-Aventis Administrative Office

Athens, Greece

Sanofi-Aventis Administrative Office

Budapest, Hungary

Sanofi-Aventis Administrative Office

Netanya, Israel

Key Dates

Start Date

May 1, 2005

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

September 15, 2008

Enrollment

150

Estimated participants

Conditions

Congestive Heart Failure

Interventions

SR121463B

DRUG

Sponsors

Lead Sponsor

Sanofi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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