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NCT00543647
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
Phase 1 trial testing Fenofibrate 160 mg tablet in Healthy Volunteers in 24 participants. Completed in 1 March 2003.
Quick facts
| Lead sponsor | Solvay Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 August 2002 |
| Estimated completion | 1 March 2003 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Fenofibrate 160 mg tablet — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Solvay Pharmaceuticals — full company profile →
Who can join
Adults 30 to 60, any sex, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Glomerular filtration rate (GFR) assessed by the measure of inulin clearance
Time frame: After two periods of 6 weeks treatment (fenofibrate and placebo in cross-over) separated by a 6wks wash out
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00543647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00543647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Solvay Pharmaceuticals
- Last refreshed: 16 January 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00543647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing