NCT00362206

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
5 countries

41 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

August 8, 2006

Last Update Submit

July 7, 2009

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatinHyperlipidemia Combined

Outcome Measures

Primary Outcomes (3)

  • Percent change from baseline to 12 weeks of treatment in 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 12 weeks of treatment in Triglycerides

    24 weeks

  • Percent change from baseline to 12 weeks of treatment in HDL-C

    24 weeks

  • Percent change from baseline to 12 weeks of treatment in LDL-C

    24 weeks

Study Arms (3)

1

EXPERIMENTAL
Drug: Fenofibrate/Simvastatin

2

EXPERIMENTAL
Drug: Fenofibrate/Simvastatin

3

ACTIVE COMPARATOR
Drug: Pravastatin

Interventions

Fenofibrate/SimvastatinDRUG

Combination of Fenofibrate and Simvastatin 20mg

1
PravastatinDRUG

Pravastatin 40 mg

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mixed dyslipidemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Site 40

Athens, Greece

Location

Site 39

Ioannina, Greece

Location

Site 41

Thessaloniki, Greece

Location

Site 37

Beer Yaakov, Israel

Location

Site 19

Haifa, Israel

Location

Site 22

Holon, Israel

Location

Site 18

Jerusalem, Israel

Location

Site 38

Kfar Saba, Israel

Location

Site 17

Ramat Gan, Israel

Location

Site 21

Ramat Gan, Israel

Location

Site 20

Rehovot, Israel

Location

Site 24

Safed, Israel

Location

Site 23

Tel Aviv, Israel

Location

Site 5

Arad, Romania

Location

Site 7

Bacau, Romania

Location

Site 1

Bucharest, Romania

Location

Site 6

Cluj-Napoca, Romania

Location

Site 4

Oradea, Romania

Location

Site 3

Ploieşti, Romania

Location

Site 2

Târgu Mureş, Romania

Location

Site 27

Barnaul, Russia

Location

Site 31

Kemerovo, Russia

Location

Site 32

Krasnoyarsk, Russia

Location

Site 25

Moscow, Russia

Location

Site 28

Novosibirsk, Russia

Location

Site 29

Saint Petersburg, Russia

Location

Site 26

Smolensk, Russia

Location

Site 30

Voronezh, Russia

Location

Site 10

Alberton, South Africa

Location

Site 9

Bloemfontein, South Africa

Location

Site 14

Cape Town, South Africa

Location

Site 35

Durban, South Africa

Location

Site 36

eMkhomazi, South Africa

Location

Site 33

Hillcrest, South Africa

Location

Site 34

Kempton Park, South Africa

Location

Site 16

Komatipoort, South Africa

Location

Site 13

Krugersdorp, South Africa

Location

Site 11

Parow, South Africa

Location

Site 12

Port Elizabeth, South Africa

Location

Site 8

Pretoria, South Africa

Location

Site 15

Worcester, South Africa

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

FenofibrateSimvastatinPravastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

ZA(13)RU(8)GR(3)RO(7)IL(10)