Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

NCT ID: NCT00362206

Last Updated: 2009-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Fenofibrate/Simvastatin

Intervention Type DRUG

Combination of Fenofibrate and Simvastatin 20mg

2

Group Type EXPERIMENTAL

Fenofibrate/Simvastatin

Intervention Type DRUG

Combination of Fenofibrate and Simvastatin 40 mg

3

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

Pravastatin 40 mg

Interventions

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Fenofibrate/Simvastatin

Combination of Fenofibrate and Simvastatin 20mg

Intervention Type DRUG

Fenofibrate/Simvastatin

Combination of Fenofibrate and Simvastatin 40 mg

Intervention Type DRUG

Pravastatin

Pravastatin 40 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 40

Athens, , Greece

Site Status

Site 39

Ioannina, , Greece

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Site 41

Thessaloniki, , Greece

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Site 37

Beer Yaakov, , Israel

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Site 19

Haifa, , Israel

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Site 22

Holon, , Israel

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Site 18

Jerusalem, , Israel

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Site 38

Kfar Saba, , Israel

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Site 17

Ramat Gan, , Israel

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Site 21

Ramat Gan, , Israel

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Site 20

Rehovot, , Israel

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Site 24

Safed, , Israel

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Site 23

Tel Aviv, , Israel

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Site 5

Arad, , Romania

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Site 7

Bacau, , Romania

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Site 1

Bucharest, , Romania

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Site 6

Cluj-Napoca, , Romania

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Site 4

Oradea, , Romania

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Site 3

Ploieşti, , Romania

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Site 2

Târgu Mureş, , Romania

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Site 27

Barnaul, , Russia

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Site 31

Kemerovo, , Russia

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Site 32

Krasnoyarsk, , Russia

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Site 25

Moscow, , Russia

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Site 28

Novosibirsk, , Russia

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Site 29

Saint Petersburg, , Russia

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Site 26

Smolensk, , Russia

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Site 30

Voronezh, , Russia

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Site 10

Alberton, , South Africa

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Site 9

Bloemfontein, , South Africa

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Site 14

Cape Town, , South Africa

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Site 35

Durban, , South Africa

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Site 36

eMkhomazi, , South Africa

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Site 33

Hillcrest, , South Africa

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Site 34

Kempton Park, , South Africa

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Site 16

Komatipoort, , South Africa

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Site 13

Krugersdorp, , South Africa

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Site 11

Parow, , South Africa

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Site 12

Port Elizabeth, , South Africa

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Site 8

Pretoria, , South Africa

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Site 15

Worcester, , South Africa

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Countries

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Greece Israel Romania Russia South Africa

Other Identifiers

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2006-000515-15

Identifier Type: -

Identifier Source: secondary_id

C LF0242780-01 05 04

Identifier Type: -

Identifier Source: org_study_id

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