CompletedPhase 4

A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

United States, India121 participantsStarted 2007-01

Plain-language summary

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has a serum sodium value between 115 and 133 mEq/L * Subject is euvolemic or hypervolemic Exclusion Criteria: * Clinical evidence of volume depletion or dehydration * Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment

What they're measuring

Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2

Timeframe: 48 hours

Trial details

NCT IDNCT00435591

SponsorCumberland Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2010-04-28

View on ClinicalTrials.gov More Hyponatremia trials