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Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00379847 |
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.
Condition | Intervention | Phase |
---|---|---|
Hyponatremia |
Drug: conivaptan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia |
Enrollment: | 251 |
Study Start Date: | February 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lower dose
|
Drug: conivaptan
IV
|
2: Experimental
Higher dose
|
Drug: conivaptan
IV
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Tuscon, Arizona, United States, 85723 | |
United States, Colorado | |
Denver, Colorado, United States, 80262 | |
United States, District of Columbia | |
Washington, District of Columbia, United States, 20007 | |
United States, Georgia | |
Augusta, Georgia, United States, 30901 | |
United States, Michigan | |
Petoskey, Michigan, United States, 49700 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45219 | |
United States, South Carolina | |
Columbia, South Carolina, United States, 29209 | |
Israel | |
Hadera, Israel | |
Rechovot, Israel | |
Ashkelon, Israel | |
2 Sites | |
Safed, Israel | |
2 Sites | |
Haifa, Israel | |
2 Sites | |
Jerusalem, Israel | |
Tel-Aviv, Israel | |
Nahariya, Israel | |
Zerifin, Israel | |
Holon, Israel | |
Afula, Israel | |
South Africa | |
Amanzimototi, South Africa | |
2 Sites | |
Durban, South Africa | |
Bellville, South Africa | |
Krugersdorp, South Africa | |
4 Sites | |
Johannesburg, South Africa | |
Lyttelton, South Africa | |
Pretoria, South Africa | |
Bloemfontein, South Africa | |
Soweto, South Africa | |
Somerset West, South Africa |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 087-CL-080 |
Study First Received: | September 21, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00379847 History of Changes |
Health Authority: | United States: Food and Drug Administration; Israel: Israeli Health Ministry Pharmaceutical Administration; South Africa: Medicines Control Council |
hyponatremia hypervolemic euvolemic treatment outcomes YM087 |
Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance Metabolic Disorder |
Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance |