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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

September 12, 2008

Start Date ^ICMJE

May 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00274326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Weight; EQ-5D and pharmaco-economic assessments

Original Secondary Outcome Measures ^ICMJE

Weight; EQ-5D and pharmaco-economic assessements

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

DILIPO (DILutIonal HyPOnatremia)

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: SR121463B

Study Arm (s)

Not Provided

Publications *

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. Epub 2011 Jan 3.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00274326

Other Study ID Numbers ^ICMJE

EFC5816

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Daniel Ter-Minassian, MD

Sanofi

Information Provided By

Sanofi

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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