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

Phase 4

Completed

• Conditions: Hyponatremia; Euvolemia; Hypervolemia
• Interventions: Drug: Conivaptan; Drug: placebo

• Registration Number: NCT00435591
• Lead Sponsor: Cumberland Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-04-28
• Results First Submitted QC: 2010-04-28
• Results First Posted: 2010-05-26
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Regimen 1	placebo	Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 1	Conivaptan	Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
Dose Regimen 3	Conivaptan	Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
Dose Regimen 3	placebo	Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
Dose Regimen 4	Conivaptan	Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag
Dose Regimen 2	Conivaptan	Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule

Primary Outcome Measures

Name	Time	Method
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	48 hours	Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion.; One ISRMS has been reported for each participant \& represents the most severe state of ISR for that participant.; ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period	Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment	Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.; Change from Baseline is calculated as Time point minus Baseline.
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	24.5 hours, 48.5 hours and 96.5 hours	AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t.; Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.
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	48.5 hours	The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the "placebo loading dose + YM087 premix continuous infusion" arm will be reported.; Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium.; Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.
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	0-24.5 hours, 0-48.5 hours and 0-96.5 hours	Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline.; Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.
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	0-24.5 hours, 0-48.5 hours and 0-96.5 hours	Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L.; Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.