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| Sponsored by: |
Solvay Pharmaceuticals |
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00543647 |
Purpose
The purpose of this study was to test the effect of fenofibrate treatment on glomerular filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with normal kidney function to further investigate the increase in creatinine levels observed in fenofibrate-treated subjects.
| Condition | Intervention | Phase |
|
Healthy Volunteers |
Drug: Fenofibrate 160 mg tablet Drug: Placebo |
Phase I |
| ChemIDplus related topics: | Procetofen Inulin Creatinine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Cross-Over, Placebo-Controlled Study Evaluating the Effect of Fenofibrate 160 mg Tablets on Glomerular Filtration Rate and Other Renal Function Test in Healthy Subjects |
| Enrollment: | 24 |
| Study Start Date: | August 2002 |
| Study Completion Date: | March 2003 |
| Arms | Assigned Interventions |
| 1: Experimental | Drug: Fenofibrate 160 mg tablet |
| 2: Placebo Comparator | Drug: Placebo |
Eligibility
| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CFEN 0201 |
| First Received: | October 12, 2007 |
| Last Updated: | October 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00543647 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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