An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
1 other identifier
interventional
251
3 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2004
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedMay 2, 2014
April 1, 2014
1.3 years
September 21, 2006
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Baseline-adjusted change in AUC for serum sodium
96 Hours
Secondary Outcomes (1)
Comparison of safety between patients in each study arm
96 Hours
Study Arms (2)
1
EXPERIMENTALLower dose
2
EXPERIMENTALHigher dose
Interventions
Eligibility Criteria
You may qualify if:
- Serum sodium levels less than or equal 130mEq/L
- Euvolemic or Hypervolemic hyponatremia
You may not qualify if:
- Clinical evidence of volume depletion or dehydration
- Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency
- Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Tuscon, Arizona, 85723, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Petoskey, Michigan, 49700, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Columbia, South Carolina, 29209, United States
Unknown Facility
Afula, Israel
Unknown Facility
Ashkelon, Israel
Unknown Facility
Hadera, Israel
2 Sites
Haifa, Israel
Unknown Facility
Holon, Israel
2 Sites
Jerusalem, Israel
Unknown Facility
Nahariya, Israel
Unknown Facility
Rehovot, Israel
2 Sites
Safed, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Ẕerifin, Israel
Unknown Facility
Amanzimototi, South Africa
Unknown Facility
Bellville, South Africa
Unknown Facility
Bloemfontein, South Africa
2 Sites
Durban, South Africa
4 Sites
Johannesburg, South Africa
Unknown Facility
Krugersdorp, South Africa
Unknown Facility
Lyttelton, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Somerset West, South Africa
Unknown Facility
Soweto, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Art Wheeler, MD
Cumberland Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 25, 2006
Study Start
February 1, 2004
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
May 2, 2014
Record last verified: 2014-04