A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia Combined
Intervention: Combination of 145 mg fenofibrate and 10 mg ezetimibe (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: TG and HDL-C levels.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type IIb dyslipidemia.
Exclusion Criteria:
- Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women.
Contra-indication to fenofibrate or ezetimibe.
Locations and Contacts
Site 101, Oosteeklo, Belgium
Site 102, Genly, Belgium
Site 103, Turnhout, Belgium
Site 104, Kortrijk, Belgium
Site 105, Moen, Belgium
Site 106, Genk, Belgium
Site 107, Menen, Belgium
Site 108, Luik, Belgium
Site 109, Kortessem, Belgium
Site 110, Oostham, 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
Site 201, St Sébastian sur Loire, France
Site 202, Orvault, France
Site 203, Saint Cyr, France
Site 204, Toulon, France
Site 205, 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 210, Six Fours les Plages, France
Site 211, Le Beausset, France
Site 212, Paris Cedex, France
Site 213, Bondy, France
Site 301, Ilvesheim, Germany
Site 302, Leipzig, Germany
Site 303, Leipzig, Germany
Site 304, Frankfurt, 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 314, Mannheim, Germany
Additional Information
Starting date: January 2005
Last updated: August 31, 2007
|
