NCT00264927|CompletedPhase 3

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

SIADH

A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Sanofi ClinicalTrials.gov

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1 other identifier

EFC4489

Study Type

interventional

Target

Locations

11 countries

Sites

Timeline

RegisteredDec 2005

StartedMay 2004

CompletionSep 2007

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started May 2004

Typical duration for phase_3

Geographic Reach

11 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

May 1, 2004

Completed

1.6 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed

Last Updated

December 10, 2008

Status Verified

December 1, 2008

Enrollment Period

3.3 years

First QC Date

December 12, 2005

Last Update Submit

December 9, 2008

Conditions

Inappropriate ADH Syndrome Hyponatremia

Keywords

Inappropriate ADH SyndromeHyponatremia

Outcome Measures

Primary Outcomes (1)

Serum sodium

Secondary Outcomes (2)

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

Interventions

SR121463BDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.