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| Sponsor: | Solvay Pharmaceuticals |
|---|---|
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00349284 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| 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 |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Disease Molecular Mechanisms of Pharmacological Action Antilipemic Agents Ezetimibe Anticholesteremic Agents |
Procetofen Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Dyslipidemias Lipid Metabolism Disorders |
