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

Hyponatremia Clinical Trial

Official title:

A Phase 4, Randomized, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435591
• Other study ID #: 087-CL-084
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2007
• Last updated: April 30, 2014
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of HealthIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Euvolemia
• Hypervolemia
• Hyponatremia

Intervention

Drug:
• Conivaptan
ampoule or premix bag
• placebo
ampoule or premix bag

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  India,  Israel, 

References & Publications (1)

Kalra S, Efrati S, Arthur JM, Oliven A, Velez JC, McNutt BE, Klasen S, Abeyratne A. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 Apr 1;68(7):590-8. doi: 10.2146/ajhp100243. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	48 hours	No
Secondary	Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period	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 at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment	No
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	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.	24.5 hours, 48.5 hours and 96.5 hours	No
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	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.	48.5 hours	No
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	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.	0-24.5 hours, 0-48.5 hours and 0-96.5 hours	No
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	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.	0-24.5 hours, 0-48.5 hours and 0-96.5 hours	No

External Links

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