Hyperlipidemia Combined Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 181 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Type IIb dyslipidemia. Exclusion Criteria: - Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site 113 | Charleroi | |
| Belgium | Site 112 | Couillet | |
| Belgium | Site 115 | Dessel | |
| Belgium | Site 114 | Dour | |
| Belgium | Site 106 | Genk | |
| Belgium | Site 102 | Genly | |
| Belgium | Site 111 | Komen | |
| Belgium | Site 109 | Kortessem | |
| Belgium | Site 104 | Kortrijk | |
| Belgium | Site 108 | Luik | |
| Belgium | Site 107 | Menen | |
| Belgium | Site 105 | Moen | |
| Belgium | Site 101 | Oosteeklo | |
| Belgium | Site 110 | Oostham | |
| Belgium | Site 116 | Seraing | |
| Belgium | Site 103 | Turnhout | |
| France | Site 213 | Bondy | |
| France | Site 211 | Le Beausset | |
| France | Site 209 | Nantes | |
| France | Site 202 | Orvault | |
| France | Site 206 | Paris | |
| France | Site 208 | Paris | |
| France | Site 212 | Paris Cedex | |
| France | Site 203 | Saint Cyr | |
| France | Site 210 | Six Fours les Plages | |
| France | Site 201 | St Sébastian sur Loire | |
| France | Site 205 | St Sébastian sur Loire | |
| France | Site 207 | St Sébastian sur Loire | |
| France | Site 204 | Toulon | |
| Germany | Site 313 | Borna | |
| Germany | Site 307 | Bretten | |
| Germany | Site 306 | Dresden | |
| Germany | Site 305 | Erbach | |
| Germany | Site 304 | Frankfurt | |
| Germany | Site 308 | Frankfurt | |
| Germany | Site 311 | Frankfurt | |
| Germany | Site 301 | Ilvesheim | |
| Germany | Site 302 | Leipzig | |
| Germany | Site 303 | Leipzig | |
| Germany | Site 314 | Mannheim | |
| Germany | Site 309 | Offenbach | |
| Germany | Site 312 | Offenbach | |
| Germany | Site 310 | Rodgau |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
Belgium, France, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | TG and HDL-C levels. |