Clinical trial NCT00362206: Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin
Hyperlipidemia Combined
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 423
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 pravastatin 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 pravastatin
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin or pravastatin
* 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: Athens
country: Greece
facility: Site 40
city: Ioannina
country: Greece
facility: Site 39
city: Thessaloniki
country: Greece
facility: Site 41
city: Beer Yaakov
country: Israel
facility: Site 37
city: Haifa
country: Israel
facility: Site 19
city: Holon
country: Israel
facility: Site 22
city: Jerusalem
country: Israel
facility: Site 18
city: Kfar Saba
country: Israel
facility: Site 38
city: Ramat Gan
country: Israel
facility: Site 17
city: Ramat Gan
country: Israel
facility: Site 21
city: Rechovot
country: Israel
facility: Site 20
city: Safed
country: Israel
facility: Site 24
city: Tel-Aviv
country: Israel
facility: Site 23
city: Arad
country: Romania
facility: Site 5
city: Bacau
country: Romania
facility: Site 7
city: Bucuresti
country: Romania
facility: Site 1
city: Cluj-Napoca
country: Romania
facility: Site 6
city: Oradea
country: Romania
facility: Site 4
city: Ploiesti
country: Romania
facility: Site 3
city: Targu Mures
country: Romania
facility: Site 2
city: Barnaul
country: Russian Federation
facility: Site 27
city: Kemerovo
country: Russian Federation
facility: Site 31
city: Krasnoyarsk
country: Russian Federation
facility: Site 32
city: Moscow
country: Russian Federation
facility: Site 25
city: Novosibirsk
country: Russian Federation
facility: Site 28
city: Smolensk
country: Russian Federation
facility: Site 26
city: St. Petersburg
country: Russian Federation
facility: Site 29
city: Voronezh
country: Russian Federation
facility: Site 30
city: Alberton
country: South Africa
facility: Site 10
city: Bloemfontein
country: South Africa
facility: Site 9
city: Cape Town
country: South Africa
facility: Site 14
city: Durban
country: South Africa
facility: Site 35
city: Hillcrest
country: South Africa
facility: Site 33
city: Kempton Park
country: South Africa
facility: Site 34
city: Komatipoort
country: South Africa
facility: Site 16
city: Krugersdorp
country: South Africa
facility: Site 13
city: Parow
country: South Africa
facility: Site 11
city: Port Elizabeth
country: South Africa
facility: Site 12
city: Pretoria
country: South Africa
facility: Site 8
city: Umkomaas
country: South Africa
facility: Site 36
city: Worcester
country: South Africa
facility: Site 15
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: