DILIPO (DILutIonal HyPOnatremia)

Congestive Heart Failure Clinical Trial

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 With Dilutional Hyponatremia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274326
• Other study ID #: EFC5816
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: September 12, 2008
• Start date: May 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Hyponatremia

Intervention

Drug:
• SR121463B

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Denmark	Sanofi-Aventis Administrative Office	Horsholm
Greece	Sanofi-Aventis Administrative Office	Athens
Hungary	Sanofi-Aventis Administrative Office	Budapest
Israel	Sanofi-Aventis Administrative Office	Natanya
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Romania	Sanofi-Aventis Administrative Office	Bucuresti
South Africa	Sanofi-Aventis Administrative Office	Midrand
Sweden	Sanofi-Aventis Administrative Office	Bromma
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFICACY:Serum Sodium
Primary	SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
Primary	PHARMACOKINETICS:Plasma SR121463B concentrations
Secondary	Weight; EQ-5D and pharmaco-economic assessments

External Links

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