An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyponatremia
Intervention: conivaptan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
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.
Clinical Details
Official title: A 4-Day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Baseline-adjusted change in AUC for serum sodium
Secondary outcome: Comparison of safety between patients in each study arm
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tel-Aviv, Israel
Rechovot, Israel
Ashkelon, Israel
2 Sites, Safed, Israel
2 Sites, Haifa, Israel
2 Sites, Jerusalem, Israel
Hadera, Israel
Nahariya, Israel
Zerifin, Israel
Holon, Israel
Afula, Israel
Amanzimototi, South Africa
2 Sites, Durban, South Africa
Bellville, South Africa
Somerset West, South Africa
4 Sites, Johannesburg, South Africa
Lyttelton, South Africa
Pretoria, South Africa
Bloemfontein, South Africa
Soweto, South Africa
Krugersdorp, South Africa
Tuscon, Arizona 85723, United States
Denver, Colorado 80262, United States
Washington, District of Columbia 20007, United States
Augusta, Georgia 30901, United States
Petoskey, Michigan 49700, United States
Cincinnati, Ohio 45219, United States
Columbia, South Carolina 29209, United States
Additional Information
Starting date: February 2004
Ending date: June 2005
Last updated: March 30, 2008
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