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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: |
NCT00380575 |
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Date of registration:
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22/09/2006 |
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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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Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
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Scientific title:
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A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia |
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Date of first enrolment:
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August 2000 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00380575 |
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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: Double-Blind, 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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Canada
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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 115 to < 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: YM087
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Primary Outcome(s)
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The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).
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Secondary ID(s)
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087-CL-027
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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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