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Sponsors and Collaborators: |
Astellas Pharma Inc Parke-Davis |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00492037 |
Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia
Condition | Intervention | Phase |
---|---|---|
Hyponatremia |
Drug: YM087 oral |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Bruxelles, Belgium | |
Liege, Belgium | |
Tournai, Belgium | |
Finland | |
Jyväskylä, Finland | |
Turku, Finland | |
France | |
Garches, France | |
Limoges, France | |
Paris Cedex 10, France | |
Germany | |
Dresdan, Germany | |
Bad Nauheim, Germany | |
Munchen, Germany | |
Berlin, Germany | |
Göttingen, Germany | |
Italy | |
Pisa, Italy | |
Pavia, Italy | |
Ferrara, Italy | |
Verona, Italy | |
Netherlands | |
Groningen, Netherlands | |
Leiden, Netherlands | |
Nijmegen, Netherlands | |
Delft, Netherlands | |
Poland | |
Warsaw, Poland | |
Wroclaw, Poland | |
Radomsko, Poland | |
Spain | |
Barcelona, Spain | |
Cordoba, Spain | |
Madrid, Spain | |
United Kingdom | |
Manchester, United Kingdom | |
Cardiff, United Kingdom |
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Study ID Numbers: | 087-CL-043, 1025-023 |
Study First Received: | June 25, 2007 |
Last Updated: | June 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00492037 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hyponatremia hypervolemic euvolemic conivaptan |
Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance Metabolic Disorder |
Metabolic Diseases Hyponatremia Water-Electrolyte Imbalance |