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Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fenofibrate / simvastatin
Atorvastatin
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus atorvastatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mixed dyslipidemia. Exclusion Criteria: Known hypersensitivity to fenofibrates or simvastatin or atorvastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin or atorvastatin Unstable or severe cardiac disease

Sites / Locations

  • Site 501
  • Site 505
  • Site 503
  • Site 506
  • Site 500
  • Site 502
  • Site 504
  • Site 507
  • Site 509
  • Site 511
  • Site 508
  • Site 510
  • Site 109
  • Site 117
  • Site 101
  • Site 114
  • Site 116
  • Site 107
  • Site 111
  • Site 113
  • Site 108
  • Site 100
  • Site 104
  • Site 110
  • Site 115
  • Site 103
  • Site 106
  • Site 118
  • Site 102
  • Site 203
  • Site 204
  • Site 205
  • Site 206
  • Site 202
  • Site 208
  • Site 207
  • Site 201
  • Site 209
  • Site 200
  • Site 301
  • Site 307
  • Site 310
  • Site 311
  • Site 312
  • Site 309
  • Site 302
  • Site 305
  • Site 306
  • Site 304
  • Site 308
  • Site 303
  • Site 300
  • Site 416
  • Site 401
  • Site 412
  • Site 402
  • Site 404
  • Site 408
  • Site 410
  • Site 414
  • Site 406
  • Site 407
  • Site 409
  • Site 411
  • Site 405
  • Site 413
  • Site 400
  • Site 415

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline to 12 weeks of treatment in Triglycerides
Percent change from baseline to 12 weeks of treatment in HDL-C
Percent change from baseline to 12 weeks of treatment in LDL-C

Secondary Outcome Measures

Percent change from baseline to 12 weeks of treatment in Triglycerides
Percent change from baseline to 12 weeks of treatment in HDL-C
Percent change from baseline to 12 weeks of treatment in LDL-C

Full Information

First Posted
August 11, 2006
Last Updated
July 7, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00362934
Brief Title
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
Official Title
A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fenofibrate / simvastatin
Intervention Description
Combination of fenofibrate and simvastatin 20 mg and 40 mg
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 10 mg and 20mg
Primary Outcome Measure Information:
Title
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time Frame
12 weeks
Title
Percent change from baseline to 12 weeks of treatment in HDL-C
Time Frame
12 weeks
Title
Percent change from baseline to 12 weeks of treatment in LDL-C
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline to 12 weeks of treatment in Triglycerides
Time Frame
24 weeks
Title
Percent change from baseline to 12 weeks of treatment in HDL-C
Time Frame
24 weeks
Title
Percent change from baseline to 12 weeks of treatment in LDL-C
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mixed dyslipidemia. Exclusion Criteria: Known hypersensitivity to fenofibrates or simvastatin or atorvastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin or atorvastatin Unstable or severe cardiac disease
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 501
City
Haskovo
Country
Bulgaria
Facility Name
Site 505
City
Pleven
Country
Bulgaria
Facility Name
Site 503
City
Plovdiv
Country
Bulgaria
Facility Name
Site 506
City
Plovdiv
Country
Bulgaria
Facility Name
Site 500
City
Sofia
Country
Bulgaria
Facility Name
Site 502
City
Sofia
Country
Bulgaria
Facility Name
Site 504
City
Sofia
Country
Bulgaria
Facility Name
Site 507
City
Sofia
Country
Bulgaria
Facility Name
Site 509
City
Sofia
Country
Bulgaria
Facility Name
Site 511
City
Sofia
Country
Bulgaria
Facility Name
Site 508
City
Varna
Country
Bulgaria
Facility Name
Site 510
City
Varna
Country
Bulgaria
Facility Name
Site 109
City
Chrudim
Country
Czech Republic
Facility Name
Site 117
City
Havirov
Country
Czech Republic
Facility Name
Site 101
City
Olomouc
Country
Czech Republic
Facility Name
Site 114
City
Olomouc
Country
Czech Republic
Facility Name
Site 116
City
Ostrava
Country
Czech Republic
Facility Name
Site 107
City
Pardubice
Country
Czech Republic
Facility Name
Site 111
City
Pardubice
Country
Czech Republic
Facility Name
Site 113
City
Plzen
Country
Czech Republic
Facility Name
Site 108
City
Praha 1
Country
Czech Republic
Facility Name
Site 100
City
Praha 2
Country
Czech Republic
Facility Name
Site 104
City
Praha 5
Country
Czech Republic
Facility Name
Site 110
City
Praha 6
Country
Czech Republic
Facility Name
Site 115
City
Praha
Country
Czech Republic
Facility Name
Site 103
City
Teplice
Country
Czech Republic
Facility Name
Site 106
City
Trutnov
Country
Czech Republic
Facility Name
Site 118
City
Unicov
Country
Czech Republic
Facility Name
Site 102
City
Usti nad Orlici
Country
Czech Republic
Facility Name
Site 203
City
Berlin
Country
Germany
Facility Name
Site 204
City
Bochum
Country
Germany
Facility Name
Site 205
City
Dresden
Country
Germany
Facility Name
Site 206
City
Gorlitz
Country
Germany
Facility Name
Site 202
City
Hamburg
Country
Germany
Facility Name
Site 208
City
Karlsruhe
Country
Germany
Facility Name
Site 207
City
Leipzig
Country
Germany
Facility Name
Site 201
City
Magdeburg
Country
Germany
Facility Name
Site 209
City
Nuernberg
Country
Germany
Facility Name
Site 200
City
Unterschneidheim
Country
Germany
Facility Name
Site 301
City
Banska Bystrica
Country
Slovakia
Facility Name
Site 307
City
Bratislava
Country
Slovakia
Facility Name
Site 310
City
Bratislava
Country
Slovakia
Facility Name
Site 311
City
Bratislava
Country
Slovakia
Facility Name
Site 312
City
Bratislava
Country
Slovakia
Facility Name
Site 309
City
Dolny kubin
Country
Slovakia
Facility Name
Site 302
City
Kosice
Country
Slovakia
Facility Name
Site 305
City
Lucenec
Country
Slovakia
Facility Name
Site 306
City
Nitra
Country
Slovakia
Facility Name
Site 304
City
Nove Zamky
Country
Slovakia
Facility Name
Site 308
City
Presov
Country
Slovakia
Facility Name
Site 303
City
Vrable
Country
Slovakia
Facility Name
Site 300
City
Zilina
Country
Slovakia
Facility Name
Site 416
City
Donetsk
Country
Ukraine
Facility Name
Site 401
City
Kharkov
Country
Ukraine
Facility Name
Site 412
City
Kiev
Country
Ukraine
Facility Name
Site 402
City
Kyiv
Country
Ukraine
Facility Name
Site 404
City
Kyiv
Country
Ukraine
Facility Name
Site 408
City
Kyiv
Country
Ukraine
Facility Name
Site 410
City
Kyiv
Country
Ukraine
Facility Name
Site 414
City
Lutsk
Country
Ukraine
Facility Name
Site 406
City
Lviv
Country
Ukraine
Facility Name
Site 407
City
Odessa
Country
Ukraine
Facility Name
Site 409
City
Odessa
Country
Ukraine
Facility Name
Site 411
City
Odessa
Country
Ukraine
Facility Name
Site 405
City
Simferopol
Country
Ukraine
Facility Name
Site 413
City
Uzhorod
Country
Ukraine
Facility Name
Site 400
City
Vinnitsa
Country
Ukraine
Facility Name
Site 415
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

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