Clinical trial NCT00352183: Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: Hyperlipidemia Combined
Combination of fenofibrate and simvastatin
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Mixed dyslipidemia

Exclusion Criteria:

* Diabetes,
* Known hypersensitivity to fenofibrate or simvastatin,
* Pregnant or lactating women,
* Contra-indication to fenofibrate or simvastatin,
* Unstable or severe cardiac disease.

Primary outcomes:
measure: Triglycerides
timeFrame: 12 weeks
measure: Percent change from baseline to 12 weeks of treatment in HDL-C
timeFrame: 12 weeks
measure: Percent change from baseline to 12 weeks of treatment in LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change from baseline to 24 weeks of treatment in Triglycerides
timeFrame: 24 weeks
measure: Percent change from baseline to 24 weeks of treatment in HDL-C
timeFrame: 24 weeks
measure: Percent change from baseline to 24 weeks of treatment in LDL-C
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Site 204
city: Adelaide
country: Australia
facility: Site 214
city: Bendigo
country: Australia
facility: Site 203
city: Brisbane
country: Australia
facility: Site 207
city: Brisbane
country: Australia
facility: Site 208
city: Brisbane
country: Australia
facility: Site 221
city: Burnie
country: Australia
facility: Site 202
city: Camperdown
country: Australia
facility: Site 201
city: Coffs Harbour
country: Australia
facility: Site 220
city: Daw Park
country: Australia
facility: Site 218
city: Elizabeth Vale
country: Australia
facility: Site 212
city: Fitzroy
country: Australia
facility: Site 217
city: Fremantle
country: Australia
facility: Site 222
city: Geelong
country: Australia
facility: Site 216
city: Ingleburn
country: Australia
facility: Site 225
city: Kippa-ring
country: Australia
facility: Site 213
city: Launceston
country: Australia
facility: Site 209
city: Liverpool
country: Australia
facility: Site 219
city: Malvern
country: Australia
facility: Site 223
city: Meadowbrook
country: Australia
facility: Site 211
city: Miranda
country: Australia
facility: Site 224
city: Nambour
country: Australia
facility: Site 210
city: Parkville
country: Australia
facility: Site 205
city: Sale
country: Australia
facility: Site 206
city: Sydney
country: Australia
facility: Site 215
city: Tallinn
country: Estonia
facility: Site 301
city: Tallinn
country: Estonia
facility: Site 302
city: Tallinn
country: Estonia
facility: Site 303
city: Tallinn
country: Estonia
facility: Site 305
city: Tallinn
country: Estonia
facility: Site 306
city: Tartu
country: Estonia
facility: Site 304
city: Tartu
country: Estonia
facility: Site 307
city: Balatonfured
country: Hungary
facility: Site 603
city: Budapest
country: Hungary
facility: Site 605
city: Budapest
country: Hungary
facility: Site 608
city: Gyongyos
country: Hungary
facility: Site 604
city: Gyor
country: Hungary
facility: Site 602
city: Hodmezovasarhely
country: Hungary
facility: Site 610
city: Kecskemet
country: Hungary
facility: Site 609
city: Miskolc
country: Hungary
facility: Site 601
city: Sopron
country: Hungary
facility: Site 607
city: Szekesfehervar
country: Hungary
facility: Site 606
city: Daugavpils
country: Latvia
facility: Site 403
city: Jekabpils
country: Latvia
facility: Site 406
city: Ogre
country: Latvia
facility: Site 401
city: Riga
country: Latvia
facility: Site 402
city: Riga
country: Latvia
facility: Site 405
city: Tukums
country: Latvia
facility: Site 404
city: Alytus
country: Lithuania
facility: Site 502
city: Kaunas
country: Lithuania
facility: Site 503
city: Kaunas
country: Lithuania
facility: Site 506
city: Klaipeda
country: Lithuania
facility: Site 505
city: Klaipeda
country: Lithuania
facility: Site 507
city: Palanga
country: Lithuania
facility: Site 508
city: Siauliai
country: Lithuania
facility: Site 504
city: Vilnius
country: Lithuania
facility: Site 501
city: Auckland
country: New Zealand
facility: Site 102
city: Auckland
country: New Zealand
facility: Site 103
city: Blenheim
country: New Zealand
facility: Site 107
city: Christchurch
country: New Zealand
facility: Site 101
city: Dunedin
country: New Zealand
facility: Site 108
city: Hamilton
country: New Zealand
facility: Site 104
city: Hastings
country: New Zealand
facility: Site 111
city: Nelson
country: New Zealand
facility: Site 106
city: Newtown, Wellington
country: New Zealand
facility: Site 110
city: Takapuna, Auckland
country: New Zealand
facility: Site 109
city: Tauranga
country: New Zealand
facility: Site 105
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: