An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Overview
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.
Full Title of Study: “A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2005
Interventions
- Drug: conivaptan
- IV
Arms, Groups and Cohorts
- Experimental: 1
- Lower dose
- Experimental: 2
- Higher dose
Clinical Trial Outcome Measures
Primary Measures
- Baseline-adjusted change in AUC for serum sodium
- Time Frame: 96 Hours
Secondary Measures
- Comparison of safety between patients in each study arm
- Time Frame: 96 Hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Cumberland Pharmaceuticals
- Provider of Information About this Clinical Study
- Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
- Overall Official(s)
- Art Wheeler, MD, Study Director, Cumberland Pharmaceuticals, Inc.
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