Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.
2 other identifiers
interventional
450
6 countries
67
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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 cardiovascular-diseases
Started Jan 2006
Shorter than P25 for phase_3 cardiovascular-diseases
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 13, 2006
CompletedFirst Posted
Study publicly available on registry
July 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 8, 2009
July 1, 2009
2.6 years
July 13, 2006
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Triglycerides
12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
12 weeks
Secondary Outcomes (3)
Percent change from baseline to 24 weeks of treatment in Triglycerides
24 weeks
Percent change from baseline to 24 weeks of treatment in HDL-C
24 weeks
Percent change from baseline to 24 weeks of treatment in LDL-C
24 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mixed dyslipidemia
You may not qualify if:
- Diabetes,
- Known hypersensitivity to fenofibrate or simvastatin,
- Pregnant or lactating women,
- Contra-indication to fenofibrate or simvastatin,
- Unstable or severe cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Site 204
Adelaide, Australia
Site 214
Adelaide, Australia
Site 203
Bendigo, Australia
Site 207
Brisbane, Australia
Site 208
Brisbane, Australia
Site 221
Brisbane, Australia
Site 202
Burnie, Australia
Site 201
Camperdown, Australia
Site 220
Coffs Harbour, Australia
Site 218
Daw Park, Australia
Site 212
Elizabeth Vale, Australia
Site 217
Fitzroy, Australia
Site 222
Fremantle, Australia
Site 216
Geelong, Australia
Site 225
Ingleburn, Australia
Site 213
Kippa-Ring, Australia
Site 209
Launceston, Australia
Site 219
Liverpool, Australia
Site 223
Malvern, Australia
Site 211
Meadowbrook, Australia
Site 224
Miranda, Australia
Site 210
Nambour, Australia
Site 205
Parkville, Australia
Site 206
Sale, Australia
Site 215
Sydney, Australia
Site 301
Tallinn, Estonia
Site 302
Tallinn, Estonia
Site 303
Tallinn, Estonia
Site 305
Tallinn, Estonia
Site 306
Tallinn, Estonia
Site 304
Tartu, Estonia
Site 307
Tartu, Estonia
Site 603
Balatonfüred, Hungary
Site 605
Budapest, Hungary
Site 608
Budapest, Hungary
Site 604
Gyöngyös, Hungary
Site 602
Győr, Hungary
Site 610
Hódmezővásárhely, Hungary
Site 609
Kecskemét, Hungary
Site 601
Miskolc, Hungary
Site 607
Sopron, Hungary
Site 606
Székesfehérvár, Hungary
Site 403
Daugavpils, Latvia
Site 406
Jēkabpils, Latvia
Site 401
Ogre, Latvia
Site 402
Riga, Latvia
Site 405
Riga, Latvia
Site 404
Tukums, Latvia
Site 502
Alytus, Lithuania
Site 503
Kaunas, Lithuania
Site 506
Kaunas, Lithuania
Site 505
Klaipėda, Lithuania
Site 507
Klaipėda, Lithuania
Site 508
Palanga, Lithuania
Site 504
Šiauliai, Lithuania
Site 501
Vilnius, Lithuania
Site 102
Auckland, New Zealand
Site 103
Auckland, New Zealand
Site 107
Blenheim, New Zealand
Site 101
Christchurch, New Zealand
Site 108
Dunedin, New Zealand
Site 104
Hamilton, New Zealand
Site 111
Hastings, New Zealand
Site 106
Nelson, New Zealand
Site 110
Newtown, Wellington, New Zealand
Site 109
Takapuna, Auckland, New Zealand
Site 105
Tauranga, New Zealand
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2006
First Posted
July 14, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 8, 2009
Record last verified: 2009-07