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

Trial Health

On Track

Trial Health Score

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

Enrollment

150

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started May 2005

Geographic Reach

15 countries

15 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

2.2 years study duration

Study Start

First participant enrolled

May 1, 2005

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed

Last Updated

September 15, 2008

Status Verified

September 1, 2008

Enrollment Period

2.2 years

First QC Date

January 9, 2006

Last Update Submit

September 12, 2008

Conditions

Congestive Heart Failure

Keywords

Hyponatremia

Outcome Measures

Primary Outcomes (3)

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

Secondary Outcomes (1)

Weight; EQ-5D and pharmaco-economic assessments

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 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.