Phase 3
N=50
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Hyponatremia
Bottom Line
View on ClinicalTrials.gov: NCT00478192 ↗Enrolled (actual)
50
Serious AEs
26.5%
Results posted
Apr 2010
Primary outcome: Primary: Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. — 126.03; 126.39; 125.55; 130.4 mEq/L — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Conivaptan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. |
126.03; 126.39; 125.55; 130.4; 133.4; 127.6 | 0.028 sig |
| SECONDARY Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment |
126.03; 126.39; 125.55; 128.03; 128.47; 125.80 | — |
| SECONDARY Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium |
16.43 | — |
| SECONDARY Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours |
12; 17; 2 | — |
| SECONDARY Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours |
6; 11; 0 | — |
| SECONDARY Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours |
142.72; 244.17; 23.21 | 0.079 |
| SECONDARY Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment |
6.76; 39.86; 18.66; 355.65; 405.21; 136.22 | — |
| SECONDARY Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment |
-53.87; 6.55; -34.90; -972.29; -611.14; -416.71 | — |
Summary
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
Eligibility Criteria
Inclusion Criteria
- Euvolemic or hypervolemic (edematous) based on clinical presentation
- Serum sodium between 115 and 130mEq/L at baseline
Exclusion Criteria
- Clinical presentation of volume depletion or dehydration
Data sourced from ClinicalTrials.gov (NCT00478192). 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.