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Trial record 10 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

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

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ClinicalTrials.gov Identifier: NCT00349284
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : September 3, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Combined Drug: Combination of 145 mg fenofibrate and 10 mg ezetimibe Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2005

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Primary Outcome Measures :
  1. TG and HDL-C levels.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type IIb dyslipidemia.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349284


Locations
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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, Belgium
France
Site 213
Bondy, France
Site 211
Le Beausset, France
Site 209
Nantes, France
Site 202
Orvault, France
Site 212
Paris Cedex, France
Site 206
Paris, France
Site 208
Paris, 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, France
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, Germany
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00349284     History of Changes
Other Study ID Numbers: C LF 178P 04 01
2004-002408-13
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: September 3, 2007
Last Verified: August 2007

Keywords provided by Solvay Pharmaceuticals:
Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe

Additional relevant MeSH terms:
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Hyperinsulinism
Fenofibrate
Metabolic Syndrome
Hyperlipidemias
Hyperlipoproteinemias
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents