NCT00264914|CompletedPhase 3

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

SIADH Safety

An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Sanofi ClinicalTrials.gov

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3 other identifiers

SFY5904LTS10208EudraCT : 2004-005239-35

Study Type

interventional

Target

Locations

11 countries

Sites

Timeline

RegisteredDec 2005

StartedJul 2005

CompletionAug 2007

Brief Summary

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.

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 Jul 2005

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

2.1 years study duration

Study Start

First participant enrolled

July 1, 2005

Completed

5 months 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

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed

Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

2.1 years

First QC Date

December 12, 2005

Last Update Submit

January 19, 2009

Conditions

Inappropriate ADH Syndrome Hyponatremia

Keywords

Inappropriate ADH SyndromeHyponatremia

Outcome Measures

Primary Outcomes (1)

Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry

Secondary Outcomes (1)

Serum sodium

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 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

Contact the study team to confirm eligibility.