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

NCT ID: NCT00349284

Last Updated: 2007-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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

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Conditions

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Hyperlipidemia Combined

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Combination of 145 mg fenofibrate and 10 mg ezetimibe

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type IIb dyslipidemia.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 113

Charleroi, , Belgium

Site Status

Site 111

Comines, , Belgium

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Site 112

Couillet, , Belgium

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Site 115

Dessel, , Belgium

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Site 114

Dour, , Belgium

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Site 106

Genk, , Belgium

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Site 102

Genly, , Belgium

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Site 109

Kortessem, , Belgium

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Site 104

Kortrijk, , Belgium

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Site 108

Liège, , Belgium

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Site 107

Menen, , Belgium

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Site 105

Moen, , Belgium

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Site 101

Oosteeklo, , Belgium

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Site 110

Oostham, , Belgium

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Site 116

Seraing, , Belgium

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Site 103

Turnhout, , Belgium

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Site 213

Bondy, , France

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Site 211

Le Beausset, , France

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Site 209

Nantes, , France

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Site 202

Orvault, , France

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Site 206

Paris, , France

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Site 208

Paris, , France

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Site 212

Paris, , France

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Site 201

Saint Sébastian Sur Loire, , France

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Site 205

Saint Sébastian Sur Loire, , France

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Site 207

Saint Sébastian Sur Loire, , France

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Site 203

Saint-Cyr, , France

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Site 210

Six-Fours-les-Plages, , France

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Site 204

Toulon, , France

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Site 313

Borna, , Germany

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Site 307

Bretten, , Germany

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Site 306

Dresden, , Germany

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Site 305

Erbach im Odenwald, , Germany

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Site 304

Frankfurt, , Germany

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Site 308

Frankfurt, , Germany

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Site 311

Frankfurt, , Germany

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Site 301

Ilvesheim, , Germany

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Site 302

Leipzig, , Germany

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Site 303

Leipzig, , Germany

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Site 314

Mannheim, , Germany

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Site 309

Offenbach, , Germany

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Site 312

Offenbach, , Germany

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Site 310

Rodgau, , Germany

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Countries

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Belgium France Germany

References

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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.

Reference Type DERIVED
PMID: 19331437 (View on PubMed)

Other Identifiers

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2004-002408-13

Identifier Type: -

Identifier Source: secondary_id

C LF 178P 04 01

Identifier Type: -

Identifier Source: org_study_id