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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00349284 |
Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.
Condition | Intervention | Phase |
---|---|---|
Hyperlipidemia Combined |
Drug: Combination of 145 mg fenofibrate and 10 mg ezetimibe |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Site 101 | |
Oosteeklo, Belgium | |
Site 102 | |
Genly, Belgium | |
Site 103 | |
Turnhout, Belgium | |
Site 104 | |
Kortrijk, Belgium | |
Site 105 | |
Moen, Belgium | |
Site 110 | |
Oostham, Belgium | |
Site 107 | |
Menen, Belgium | |
Site 108 | |
Luik, Belgium | |
Site 109 | |
Kortessem, Belgium | |
Site 106 | |
Genk, Belgium | |
Site 111 | |
Komen, Belgium | |
Site 112 | |
Couillet, Belgium | |
Site 113 | |
Charleroi, Belgium | |
Site 114 | |
Dour, Belgium | |
Site 115 | |
Dessel, Belgium | |
Site 116 | |
Seraing, Belgium | |
France | |
Site 205 | |
St Sébastian sur Loire, France | |
Site 202 | |
Orvault, France | |
Site 203 | |
Saint Cyr, France | |
Site 204 | |
Toulon, France | |
Site 201 | |
St Sébastian sur Loire, France | |
Site 206 | |
Paris, France | |
Site 207 | |
St Sébastian sur Loire, France | |
Site 208 | |
Paris, France | |
Site 209 | |
Nantes, France | |
Site 213 | |
Bondy, France | |
Site 211 | |
Le Beausset, France | |
Site 212 | |
Paris Cedex, France | |
Site 210 | |
Six Fours les Plages, France | |
Germany | |
Site 301 | |
Ilvesheim, Germany | |
Site 302 | |
Leipzig, Germany | |
Site 303 | |
Leipzig, Germany | |
Site 314 | |
Mannheim, Germany | |
Site 305 | |
Erbach, Germany | |
Site 306 | |
Dresden, Germany | |
Site 307 | |
Bretten, Germany | |
Site 308 | |
Frankfurt, Germany | |
Site 309 | |
Offenbach, Germany | |
Site 310 | |
Rodgau, Germany | |
Site 311 | |
Frankfurt, Germany | |
Site 312 | |
Offenbach, Germany | |
Site 313 | |
Borna, Germany | |
Site 304 | |
Frankfurt, Germany |
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Study ID Numbers: | C LF 178P 04 01, 2004-002408-13 |
Study First Received: | July 5, 2006 |
Last Updated: | August 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00349284 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe |
Metabolic Diseases Hyperlipidemias Ezetimibe Metabolic disorder |
Procetofen Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Syndrome Anticholesteremic Agents Pharmacologic Actions |