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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00274326




Registration number
NCT00274326
Ethics application status
Date submitted
9/01/2006
Date registered
10/01/2006
Date last updated
15/09/2008

Titles & IDs
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
Secondary ID [1] 0 0
EFC5816
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR121463B

Treatment: Drugs: SR121463B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
EFFICACY:Serum Sodium
Timepoint [1] 0 0
Primary outcome [2] 0 0
SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
Timepoint [2] 0 0
Primary outcome [3] 0 0
PHARMACOKINETICS:Plasma SR121463B concentrations
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Weight; EQ-5D and pharmaco-economic assessments
Timepoint [1] 0 0

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Belgium
State/province [3] 0 0
Diegem
Country [4] 0 0
Canada
State/province [4] 0 0
Laval
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Denmark
State/province [6] 0 0
Horsholm
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Israel
State/province [9] 0 0
Natanya
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
Portugal
State/province [11] 0 0
Porto Salvo
Country [12] 0 0
Romania
State/province [12] 0 0
Bucuresti
Country [13] 0 0
South Africa
State/province [13] 0 0
Midrand
Country [14] 0 0
Sweden
State/province [14] 0 0
Bromma

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00274326
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Ter-Minassian, MD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00274326