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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00379847 |
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Date of registration:
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21/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
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Scientific title:
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A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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251 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00379847 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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South Africa
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United States
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Contacts
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Name:
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Art Wheeler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cumberland Pharmaceuticals Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyponatremia
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Intervention(s)
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Drug: conivaptan
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Primary Outcome(s)
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Baseline-adjusted change in AUC for serum sodium
[Time Frame: 96 Hours]
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Secondary Outcome(s)
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Comparison of safety between patients in each study arm
[Time Frame: 96 Hours]
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Secondary ID(s)
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087-CL-080
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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