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DILIPO (DILutIonal HyPOnatremia)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SR121463B
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Hyponatremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • sanofi-aventis Australia & New Zealand administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Outcomes

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

Full Information

First Posted
January 9, 2006
Last Updated
September 12, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00274326
Brief Title
DILIPO (DILutIonal HyPOnatremia)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Hyponatremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR121463B
Primary Outcome Measure Information:
Title
EFFICACY:Serum Sodium
Title
SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
Title
PHARMACOKINETICS:Plasma SR121463B concentrations
Secondary Outcome Measure Information:
Title
Weight; EQ-5D and pharmaco-economic assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ter-Minassian, MD
Organizational Affiliation
Sanofi
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
sanofi-aventis Australia & New Zealand administrative office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21199833
Citation
Aronson D, Verbalis JG, Mueller M, Krum H; DILIPO investigators. Short- and long-term treatment of dilutional hyponatraemia with satavaptan, a selective arginine vasopressin V2-receptor antagonist: the DILIPO study. Eur J Heart Fail. 2011 Mar;13(3):327-36. doi: 10.1093/eurjhf/hfq226. Epub 2011 Jan 3.
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
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DILIPO (DILutIonal HyPOnatremia)

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