A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

Phase 3

Completed

• Conditions: Hyperlipidemia Combined

• Registration Number: NCT00349284
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-31
• Last Update Posted: 2007-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• Type IIb dyslipidemia.

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Exclusion Criteria

• Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TG and HDL-C levels.

Trial Locations

Locations (43)

Site 113; 🇧🇪 Charleroi, Belgium

Site 114; 🇧🇪 Dour, Belgium

Site 106; 🇧🇪 Genk, Belgium

Site 111; 🇧🇪 Komen, Belgium

Site 109; 🇧🇪 Kortessem, Belgium

Site 108; 🇧🇪 Luik, Belgium

Site 107; 🇧🇪 Menen, Belgium

Site 116; 🇧🇪 Seraing, Belgium

Site 101; 🇧🇪 Oosteeklo, Belgium

Site 112; 🇧🇪 Couillet, Belgium

Site 104; 🇧🇪 Kortrijk, Belgium

Site 210; 🇫🇷 Six Fours les Plages, France

Site 313; 🇩🇪 Borna, Germany

Site 105; 🇧🇪 Moen, Belgium

Site 115; 🇧🇪 Dessel, Belgium

Site 314; 🇩🇪 Mannheim, Germany

Site 206; 🇫🇷 Paris, France

Site 203; 🇫🇷 Saint Cyr, France

Site 209; 🇫🇷 Nantes, France

Site 307; 🇩🇪 Bretten, Germany

Site 306; 🇩🇪 Dresden, Germany

Site 305; 🇩🇪 Erbach, Germany

Site 303; 🇩🇪 Leipzig, Germany

Site 201; 🇫🇷 St Sébastian sur Loire, France

Site 205; 🇫🇷 St Sébastian sur Loire, France

Site 304; 🇩🇪 Frankfurt, Germany

Site 308; 🇩🇪 Frankfurt, Germany

Site 310; 🇩🇪 Rodgau, Germany

Site 208; 🇫🇷 Paris, France

Site 202; 🇫🇷 Orvault, France

Site 311; 🇩🇪 Frankfurt, Germany

Site 213; 🇫🇷 Bondy, France

Site 301; 🇩🇪 Ilvesheim, Germany

Site 302; 🇩🇪 Leipzig, Germany

Site 312; 🇩🇪 Offenbach, Germany

Site 212; 🇫🇷 Paris Cedex, France

Site 204; 🇫🇷 Toulon, France

Site 102; 🇧🇪 Genly, Belgium

Site 110; 🇧🇪 Oostham, Belgium

Site 103; 🇧🇪 Turnhout, Belgium

Site 211; 🇫🇷 Le Beausset, France

Site 207; 🇫🇷 St Sébastian sur Loire, France

Site 309; 🇩🇪 Offenbach, Germany