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An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00379847
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : May 2, 2014
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 21, 2006
First Posted Date  ICMJE September 25, 2006
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE February 2004
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2008)
Baseline-adjusted change in AUC for serum sodium [ Time Frame: 96 Hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
The primary efficacy outcome will be baseline-adjusted change in AUC for serum sodium over the 96-hour infusion. The primary safety outcome will be to compare the safety in patients treated with 20mg/day to the safety in patients treated with 40mg/day
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2008)
Comparison of safety between patients in each study arm [ Time Frame: 96 Hours ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Official Title  ICMJE A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
Brief Summary This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyponatremia
Intervention  ICMJE Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087
Study Arms  ICMJE
  • Experimental: 1
    Lower dose
    Intervention: Drug: conivaptan
  • Experimental: 2
    Higher dose
    Intervention: Drug: conivaptan
Publications * Not Provided

*   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: March 30, 2008)
251
Original Enrollment  ICMJE
 (submitted: September 21, 2006)
250
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Serum sodium levels less than or equal 130mEq/L
  • Euvolemic or Hypervolemic hyponatremia

Exclusion Criteria:

  • Clinical evidence of volume depletion or dehydration
  • Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
  • Uncontrolled brady-or tachyarrhythmias requiring 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 Israel,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00379847
Other Study ID Numbers  ICMJE 087-CL-080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
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