Back to resultsA Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome
Primary Purpose
Hyperlipidemia Combined
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Combination of 145 mg fenofibrate and 10 mg ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia Combined focused on measuring Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe
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.
Sites / Locations
- Site 113
- Site 112
- Site 115
- Site 114
- Site 106
- Site 102
- Site 111
- Site 109
- Site 104
- Site 108
- Site 107
- Site 105
- Site 101
- Site 110
- Site 116
- Site 103
- Site 213
- Site 211
- Site 209
- Site 202
- Site 212
- Site 206
- Site 208
- Site 203
- Site 210
- Site 201
- Site 205
- Site 207
- Site 204
- Site 313
- Site 307
- Site 306
- Site 305
- Site 304
- Site 308
- Site 311
- Site 301
- Site 302
- Site 303
- Site 314
- Site 309
- Site 312
- Site 310
Outcomes
Primary Outcome Measures
TG and HDL-C levels.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349284
Brief Title
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
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia Combined
Keywords
Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
181 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Combination of 145 mg fenofibrate and 10 mg ezetimibe
Primary Outcome Measure Information:
Title
TG and HDL-C levels.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 113
City
Charleroi
Country
Belgium
Facility Name
Site 112
City
Couillet
Country
Belgium
Facility Name
Site 115
City
Dessel
Country
Belgium
Facility Name
Site 114
City
Dour
Country
Belgium
Facility Name
Site 106
City
Genk
Country
Belgium
Facility Name
Site 102
City
Genly
Country
Belgium
Facility Name
Site 111
City
Komen
Country
Belgium
Facility Name
Site 109
City
Kortessem
Country
Belgium
Facility Name
Site 104
City
Kortrijk
Country
Belgium
Facility Name
Site 108
City
Luik
Country
Belgium
Facility Name
Site 107
City
Menen
Country
Belgium
Facility Name
Site 105
City
Moen
Country
Belgium
Facility Name
Site 101
City
Oosteeklo
Country
Belgium
Facility Name
Site 110
City
Oostham
Country
Belgium
Facility Name
Site 116
City
Seraing
Country
Belgium
Facility Name
Site 103
City
Turnhout
Country
Belgium
Facility Name
Site 213
City
Bondy
Country
France
Facility Name
Site 211
City
Le Beausset
Country
France
Facility Name
Site 209
City
Nantes
Country
France
Facility Name
Site 202
City
Orvault
Country
France
Facility Name
Site 212
City
Paris Cedex
Country
France
Facility Name
Site 206
City
Paris
Country
France
Facility Name
Site 208
City
Paris
Country
France
Facility Name
Site 203
City
Saint Cyr
Country
France
Facility Name
Site 210
City
Six Fours les Plages
Country
France
Facility Name
Site 201
City
St Sébastian sur Loire
Country
France
Facility Name
Site 205
City
St Sébastian sur Loire
Country
France
Facility Name
Site 207
City
St Sébastian sur Loire
Country
France
Facility Name
Site 204
City
Toulon
Country
France
Facility Name
Site 313
City
Borna
Country
Germany
Facility Name
Site 307
City
Bretten
Country
Germany
Facility Name
Site 306
City
Dresden
Country
Germany
Facility Name
Site 305
City
Erbach
Country
Germany
Facility Name
Site 304
City
Frankfurt
Country
Germany
Facility Name
Site 308
City
Frankfurt
Country
Germany
Facility Name
Site 311
City
Frankfurt
Country
Germany
Facility Name
Site 301
City
Ilvesheim
Country
Germany
Facility Name
Site 302
City
Leipzig
Country
Germany
Facility Name
Site 303
City
Leipzig
Country
Germany
Facility Name
Site 314
City
Mannheim
Country
Germany
Facility Name
Site 309
City
Offenbach
Country
Germany
Facility Name
Site 312
City
Offenbach
Country
Germany
Facility Name
Site 310
City
Rodgau
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19331437
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.
Results Reference
derived
Learn more about this trial
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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