Clinical trial NCT00362934: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia Combined
efficacy combination fenofibrate simvastatin versus atorvastatin
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 516
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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


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

Primary outcomes:
measure: Percent change from baseline to 12 weeks of treatment in 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 12 weeks of treatment in Triglycerides
timeFrame: 24 weeks
measure: Percent change from baseline to 12 weeks of treatment in HDL-C
timeFrame: 24 weeks
measure: Percent change from baseline to 12 weeks of treatment in LDL-C
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Haskovo
country: Bulgaria
facility: Site 501
city: Pleven
country: Bulgaria
facility: Site 505
city: Plovdiv
country: Bulgaria
facility: Site 503
city: Plovdiv
country: Bulgaria
facility: Site 506
city: Sofia
country: Bulgaria
facility: Site 500
city: Sofia
country: Bulgaria
facility: Site 502
city: Sofia
country: Bulgaria
facility: Site 504
city: Sofia
country: Bulgaria
facility: Site 507
city: Sofia
country: Bulgaria
facility: Site 509
city: Sofia
country: Bulgaria
facility: Site 511
city: Varna
country: Bulgaria
facility: Site 508
city: Varna
country: Bulgaria
facility: Site 510
city: Chrudim
country: Czech Republic
facility: Site 109
city: Havirov
country: Czech Republic
facility: Site 117
city: Olomouc
country: Czech Republic
facility: Site 101
city: Olomouc
country: Czech Republic
facility: Site 114
city: Ostrava
country: Czech Republic
facility: Site 116
city: Pardubice
country: Czech Republic
facility: Site 107
city: Pardubice
country: Czech Republic
facility: Site 111
city: Plzen
country: Czech Republic
facility: Site 113
city: Praha 1
country: Czech Republic
facility: Site 108
city: Praha 2
country: Czech Republic
facility: Site 100
city: Praha 5
country: Czech Republic
facility: Site 104
city: Praha 6
country: Czech Republic
facility: Site 110
city: Praha
country: Czech Republic
facility: Site 115
city: Teplice
country: Czech Republic
facility: Site 103
city: Trutnov
country: Czech Republic
facility: Site 106
city: Unicov
country: Czech Republic
facility: Site 118
city: Usti nad Orlici
country: Czech Republic
facility: Site 102
city: Berlin
country: Germany
facility: Site 203
city: Bochum
country: Germany
facility: Site 204
city: Dresden
country: Germany
facility: Site 205
city: Gorlitz
country: Germany
facility: Site 206
city: Hamburg
country: Germany
facility: Site 202
city: Karlsruhe
country: Germany
facility: Site 208
city: Leipzig
country: Germany
facility: Site 207
city: Magdeburg
country: Germany
facility: Site 201
city: Nuernberg
country: Germany
facility: Site 209
city: Unterschneidheim
country: Germany
facility: Site 200
city: Banska Bystrica
country: Slovakia
facility: Site 301
city: Bratislava
country: Slovakia
facility: Site 307
city: Bratislava
country: Slovakia
facility: Site 310
city: Bratislava
country: Slovakia
facility: Site 311
city: Bratislava
country: Slovakia
facility: Site 312
city: Dolny kubin
country: Slovakia
facility: Site 309
city: Kosice
country: Slovakia
facility: Site 302
city: Lucenec
country: Slovakia
facility: Site 305
city: Nitra
country: Slovakia
facility: Site 306
city: Nove Zamky
country: Slovakia
facility: Site 304
city: Presov
country: Slovakia
facility: Site 308
city: Vrable
country: Slovakia
facility: Site 303
city: Zilina
country: Slovakia
facility: Site 300
city: Donetsk
country: Ukraine
facility: Site 416
city: Kharkov
country: Ukraine
facility: Site 401
city: Kiev
country: Ukraine
facility: Site 412
city: Kyiv
country: Ukraine
facility: Site 402
city: Kyiv
country: Ukraine
facility: Site 404
city: Kyiv
country: Ukraine
facility: Site 408
city: Kyiv
country: Ukraine
facility: Site 410
city: Lutsk
country: Ukraine
facility: Site 414
city: Lviv
country: Ukraine
facility: Site 406
city: Odessa
country: Ukraine
facility: Site 407
city: Odessa
country: Ukraine
facility: Site 409
city: Odessa
country: Ukraine
facility: Site 411
city: Simferopol
country: Ukraine
facility: Site 405
city: Uzhorod
country: Ukraine
facility: Site 413
city: Vinnitsa
country: Ukraine
facility: Site 400
city: Zaporozhye
country: Ukraine
facility: Site 415
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: