Phase 4
N=121
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Hyponatremia · Euvolemia · Hypervolemia
Bottom Line
View on ClinicalTrials.gov: NCT00435591 ↗Enrolled (actual)
121
Serious AEs
14.5%
Results posted
May 2010
Primary outcome: Primary: 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 — 0; 1; 17; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Conivaptan (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 1; 17; 16; 5; 7 | — |
| SECONDARY Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period |
124.6; 123.5; 124.5; 124.0; 1.2; 1.5 | — |
| SECONDARY Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours |
45.600; 70.569; 66.096; 82.470; 133.664; 194.561 | — |
| SECONDARY Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period |
24.08 | — |
| SECONDARY Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours |
6; 13; 13; 10; 13; 15 | — |
| SECONDARY Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours |
1; 6; 7; 6; 6; 13 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00435591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.