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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00264914
First received: December 12, 2005
Last updated: January 19, 2009
Last verified: January 2009
  Purpose

To determine the long-term safety and tolerability of SR121463B 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.

Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.


Condition Intervention Phase
Inappropriate ADH Syndrome
Hyponatremia
Drug: SR121463B
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry

Secondary Outcome Measures:
  • Serum sodium

Enrollment: 57
Study Start Date: July 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  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 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 any 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 (or clearance of creatine <30mL/min for where Ethics Committees require this parameter), ALT and /or AST >2x upper limit of normal
  • QTcB > 500 ms
  • Serum potassium > 5 mmol/L
  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: NCT00264914

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
sanofi-aventis Canada
Laval, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00264914     History of Changes
Other Study ID Numbers: SFY5904, LTS10208, EudraCT : 2004-005239-35
Study First Received: December 12, 2005
Last Updated: January 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Inappropriate ADH Syndrome
Hyponatremia

Additional relevant MeSH terms:
Diabetes Insipidus
Hyponatremia
Inappropriate ADH Syndrome
Syndrome
Brain Diseases
Central Nervous System Diseases
Disease
Endocrine System Diseases
Hypothalamic Diseases
Kidney Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Pituitary Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014