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

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ClinicalTrials.gov Identifier: NCT00435591
Recruitment Status : Completed
First Posted : February 15, 2007
Results First Posted : May 26, 2010
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 14, 2007
First Posted Date  ICMJE February 15, 2007
Results First Submitted Date  ICMJE April 28, 2010
Results First Posted Date  ICMJE May 26, 2010
Last Update Posted Date May 15, 2014
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2007)
  • The primary safety variable is Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
  • Safety variable: Infusion site reaction (ISR) assessments of phlebitis and infiltration based on ISR reporting scale between regimens
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
  • Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2007)
Change from baseline in serum Na at each time point over the 48 hour treatment period and 7 day follow-up period,Baseline-adjusted AUC in serum Na over the first 24 hour treatment period, the 48 hour treatment period, and the 7 day follow-up period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyponatremia
  • Euvolemia
  • Hypervolemia
Intervention  ICMJE
  • Drug: Conivaptan
    ampoule or premix bag
    Other Names:
    • YM087
    • Vaprisol
  • Drug: placebo
    ampoule or premix bag
Study Arms  ICMJE
  • Experimental: Dose Regimen 1
    Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
    Interventions:
    • Drug: Conivaptan
    • Drug: placebo
  • Experimental: Dose Regimen 2
    Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
    Intervention: Drug: Conivaptan
  • Experimental: Dose Regimen 3
    Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
    Interventions:
    • Drug: Conivaptan
    • Drug: placebo
  • Experimental: Dose Regimen 4
    Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag
    Intervention: Drug: Conivaptan
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
121
Original Enrollment  ICMJE
 (submitted: February 14, 2007)
120
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435591
Other Study ID Numbers  ICMJE 087-CL-084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cumberland Pharmaceuticals
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Cumberland Pharmaceuticals
Original Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals, Inc.
PRS Account Cumberland Pharmaceuticals
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP