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Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Primary Purpose

Inappropriate ADH Syndrome, Hyponatremia

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 Inappropriate ADH Syndrome focused on measuring Inappropriate ADH Syndrome, Hyponatremia

Eligibility Criteria

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

Inclusion Criteria: Male or female patients aged 18 years and higher. SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, and normal renal, adrenal, and thyroid functions: drug induced SIADH will be limited to carbamazepine or derivatives and antidepressants in patients in whom these drugs cannot be discontinued or easily replaced by other drugs) Serum sodium between 115 and 132 mmol/L (at least two consecutive serum sodium levels of at least 24 hours apart, from Day -6 to Day -1); for sodium levels between 125 and 132 mmol/L, the spontaneous serum sodium increase between the two assessments on Day -1 should be < 4 mmol/L Urinary osmolality >200mOsm/kg H2O Urinary sodium > 30 mmol/L Exclusion Criteria: Patients with acute postoperative SIADH Presence of dilutional hyponatremia in hypervolemic states such as congestive heart failure and liver disease with ascites Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit, …) Administration of other V2 receptor antagonists or demeclocycline or lithium within one month, thiazides diuretics or spironolactone within 15 days, and urea or loop diuretics within two days prior to study drug administration Patients with known treated or untreated adrenal deficiency Presence of untreated hypothyroidism Presence of uncontrolled diabetes with fasting glycemia > 200 mg/dL (> 11.09 mmol/L) Presence of clinical and/or electrocardiographical signs of acute myocardial infarction or acute ischemia, or nay other clinically significant abnormality according to the Investigator on a 12 lead ECG recording Administration of inducers of CYP3A4, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitor so CYP3A4within two weeks prior to study drug administration Inadequate hematological, renal and hepatic functions: hemoglobin (Hb) < 9 g/dl, neutrophils < 1,500/mm3, platelets <100,00/mm3, serum creatine>175 µmol/L, ALT and /or AST >2x upper limit of normal QTcB > 500 ms Serum potassium > 5 mmol/L

Sites / Locations

  • 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

Serum sodium

Secondary Outcome Measures

Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry

Full Information

First Posted
December 12, 2005
Last Updated
December 9, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00264927
Brief Title
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Acronym
SIADH
Official Title
A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH. The double blind period is followed by an open label extension study with flexible doses of satavaptan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inappropriate ADH Syndrome, Hyponatremia
Keywords
Inappropriate ADH Syndrome, Hyponatremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR121463B
Primary Outcome Measure Information:
Title
Serum sodium
Secondary Outcome Measure Information:
Title
Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
Title
Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry

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 years and higher. SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, and normal renal, adrenal, and thyroid functions: drug induced SIADH will be limited to carbamazepine or derivatives and antidepressants in patients in whom these drugs cannot be discontinued or easily replaced by other drugs) Serum sodium between 115 and 132 mmol/L (at least two consecutive serum sodium levels of at least 24 hours apart, from Day -6 to Day -1); for sodium levels between 125 and 132 mmol/L, the spontaneous serum sodium increase between the two assessments on Day -1 should be < 4 mmol/L Urinary osmolality >200mOsm/kg H2O Urinary sodium > 30 mmol/L Exclusion Criteria: Patients with acute postoperative SIADH Presence of dilutional hyponatremia in hypervolemic states such as congestive heart failure and liver disease with ascites Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit, …) Administration of other V2 receptor antagonists or demeclocycline or lithium within one month, thiazides diuretics or spironolactone within 15 days, and urea or loop diuretics within two days prior to study drug administration Patients with known treated or untreated adrenal deficiency Presence of untreated hypothyroidism Presence of uncontrolled diabetes with fasting glycemia > 200 mg/dL (> 11.09 mmol/L) Presence of clinical and/or electrocardiographical signs of acute myocardial infarction or acute ischemia, or nay other clinically significant abnormality according to the Investigator on a 12 lead ECG recording Administration of inducers of CYP3A4, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitor so CYP3A4within two weeks prior to study drug administration Inadequate hematological, renal and hepatic functions: hemoglobin (Hb) < 9 g/dl, neutrophils < 1,500/mm3, platelets <100,00/mm3, serum creatine>175 µmol/L, ALT and /or AST >2x upper limit of normal QTcB > 500 ms Serum potassium > 5 mmol/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
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
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

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Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

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