Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Parke-Davis
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00492037
First received: June 25, 2007
Last updated: June 1, 2010
Last verified: June 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2007 | ||||
| Last Updated Date | June 1, 2010 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change in serum sodium from Baseline Safety of each dosing regimen [ Time Frame: Beginning through end of treatment ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00492037 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Hyponatremia | ||||
| Intervention ICMJE | Drug: YM087 oral | ||||
| Study Arm (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 83 | ||||
| Completion Date | February 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium, Finland, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00492037 | ||||
| Other Study ID Numbers ICMJE | 087-CL-043, 1025-023 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | |||||
| Study Sponsor ICMJE | Astellas Pharma Inc | ||||
| Collaborators ICMJE | Parke-Davis | ||||
| Investigators ICMJE |
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| Information Provided By | Astellas Pharma Inc | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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