Clinical trial NCT00349284: A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia Combined
Keywords: Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Type IIb dyslipidemia.

Exclusion Criteria:

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

Primary outcomes:
measure: TG and HDL-C levels.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Site 113
city: Couillet
country: Belgium
facility: Site 112
city: Dessel
country: Belgium
facility: Site 115
city: Dour
country: Belgium
facility: Site 114
city: Genk
country: Belgium
facility: Site 106
city: Genly
country: Belgium
facility: Site 102
city: Komen
country: Belgium
facility: Site 111
city: Kortessem
country: Belgium
facility: Site 109
city: Kortrijk
country: Belgium
facility: Site 104
city: Luik
country: Belgium
facility: Site 108
city: Menen
country: Belgium
facility: Site 107
city: Moen
country: Belgium
facility: Site 105
city: Oosteeklo
country: Belgium
facility: Site 101
city: Oostham
country: Belgium
facility: Site 110
city: Seraing
country: Belgium
facility: Site 116
city: Turnhout
country: Belgium
facility: Site 103
city: Bondy
country: France
facility: Site 213
city: Le Beausset
country: France
facility: Site 211
city: Nantes
country: France
facility: Site 209
city: Orvault
country: France
facility: Site 202
city: Paris Cedex
country: France
facility: Site 212
city: Paris
country: France
facility: Site 206
city: Paris
country: France
facility: Site 208
city: Saint Cyr
country: France
facility: Site 203
city: Six Fours les Plages
country: France
facility: Site 210
city: St Sébastian sur Loire
country: France
facility: Site 201
city: St Sébastian sur Loire
country: France
facility: Site 205
city: St Sébastian sur Loire
country: France
facility: Site 207
city: Toulon
country: France
facility: Site 204
city: Borna
country: Germany
facility: Site 313
city: Bretten
country: Germany
facility: Site 307
city: Dresden
country: Germany
facility: Site 306
city: Erbach
country: Germany
facility: Site 305
city: Frankfurt
country: Germany
facility: Site 304
city: Frankfurt
country: Germany
facility: Site 308
city: Frankfurt
country: Germany
facility: Site 311
city: Ilvesheim
country: Germany
facility: Site 301
city: Leipzig
country: Germany
facility: Site 302
city: Leipzig
country: Germany
facility: Site 303
city: Mannheim
country: Germany
facility: Site 314
city: Offenbach
country: Germany
facility: Site 309
city: Offenbach
country: Germany
facility: Site 312
city: Rodgau
country: Germany
facility: Site 310
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Ansquer JC, Bekaert I, Guy M, Hanefeld M, Simon A; Study Investigators. Efficacy and safety of coadministration of fenofibrate and ezetimibe compared with each as monotherapy in patients with type IIb dyslipidemia and features of the metabolic syndrome: a prospective, randomized, double-blind, three-parallel arm, multicenter, comparative study. Am J Cardiovasc Drugs. 2009;9(2):91-101. doi: 10.1007/BF03256580.