DILIPO (DILutIonal HyPOnatremia)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00274326
First received: January 9, 2006
Last updated: September 12, 2008
Last verified: September 2008
  Purpose

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

Condition Intervention Phase
Congestive Heart Failure
Drug: SR121463B
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • EFFICACY:Serum Sodium
  • SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
  • PHARMACOKINETICS:Plasma SR121463B concentrations

Secondary Outcome Measures:
  • Weight; EQ-5D and pharmaco-economic assessments

Estimated Enrollment: 150
Study Start Date: May 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274326

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Daniel Ter-Minassian, MD Sanofi
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274326     History of Changes
Other Study ID Numbers: EFC5816
Study First Received: January 9, 2006
Last Updated: September 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Hyponatremia

Additional relevant MeSH terms:
Heart Failure
Hyponatremia
Heart Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014