Status:
COMPLETED
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Hyponatremia
Euvolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
Eligibility Criteria
Inclusion
- Subject has a serum sodium value between 115 and 133 mEq/L
- Subject is euvolemic or hypervolemic
Exclusion
- Clinical evidence of volume depletion or dehydration
- Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00435591
Start Date
January 1 2007
End Date
September 1 2008
Last Update
May 15 2014
Active Locations (18)
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1
Charleston, South Carolina, United States, 29425
2
Bangalore, India, 560034
3
Bangalore, India, 560099
4
Bhopal, India, 462001