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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00887627 |
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 96-hour continuous infusion of conivaptan.
Condition | Intervention | Phase |
---|---|---|
Kidney Diseases Hyponatremia |
Drug: conivaptan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan |
Estimated Enrollment: | 24 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1. Mild Renal Function Impaired Subjects: Experimental |
Drug: conivaptan hydrochloride
intravenous
|
2. Moderate Renal Function Impaired Subjects: Experimental |
Drug: conivaptan hydrochloride
intravenous
|
3. Subjects with Normal Renal Function: Experimental |
Drug: conivaptan hydrochloride
intravenous
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Astellas Pharma Global Development | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
United States, California | |
Recruiting | |
Anaheim, California, United States, 92801 |
Study Director: | Use Central Contact | Astellas Pharma Global Development |
Responsible Party: | Astellas Pharma Global Development ( Sr Manager Clinical Trials Registry ) |
Study ID Numbers: | 087-CL-094 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887627 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics Protein Binding Conivaptan Vaprisol Kidney Diseases |
Metabolic Diseases Urologic Diseases Hyponatremia |
Water-Electrolyte Imbalance Kidney Diseases Metabolic Disorder |
Metabolic Diseases Urologic Diseases Hyponatremia Water-Electrolyte Imbalance Kidney Diseases |