Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

NCT ID: NCT00352183

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

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-08-31

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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Fenofibrate/Simvastatin

Intervention Type DRUG

Combination of Fenofibrate and Simvastatin 40mg

2

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 40mg

Interventions

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Fenofibrate/Simvastatin

Combination of Fenofibrate and Simvastatin 40mg

Intervention Type DRUG

Simvastatin

Simvastatin 40mg

Intervention Type DRUG

Eligibility Criteria

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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.
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 204

Adelaide, , Australia

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Site 214

Adelaide, , Australia

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Site 203

Bendigo, , Australia

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Site 207

Brisbane, , Australia

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Site 208

Brisbane, , Australia

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Site 221

Brisbane, , Australia

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Site 202

Burnie, , Australia

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Site 201

Camperdown, , Australia

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Site 220

Coffs Harbour, , Australia

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Site 218

Daw Park, , Australia

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Site 212

Elizabeth Vale, , Australia

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Site 217

Fitzroy, , Australia

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Site 222

Fremantle, , Australia

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Site 216

Geelong, , Australia

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Site 225

Ingleburn, , Australia

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Site 213

Kippa-Ring, , Australia

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Site 209

Launceston, , Australia

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Site 219

Liverpool, , Australia

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Site 223

Malvern, , Australia

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Site 211

Meadowbrook, , Australia

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Site 224

Miranda, , Australia

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Site 210

Nambour, , Australia

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Site 205

Parkville, , Australia

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Site 206

Sale, , Australia

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Site 215

Sydney, , Australia

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Site 301

Tallinn, , Estonia

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Site 302

Tallinn, , Estonia

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Site 303

Tallinn, , Estonia

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Site 305

Tallinn, , Estonia

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Site 306

Tallinn, , Estonia

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Site 304

Tartu, , Estonia

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Site 307

Tartu, , Estonia

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Site 603

Balatonfüred, , Hungary

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Site 605

Budapest, , Hungary

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Site 608

Budapest, , Hungary

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Site 604

Gyöngyös, , Hungary

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Site 602

Győr, , Hungary

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Site 610

Hódmezővásárhely, , Hungary

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Site 609

Kecskemét, , Hungary

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Site 601

Miskolc, , Hungary

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Site 607

Sopron, , Hungary

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Site 606

Székesfehérvár, , Hungary

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Site 403

Daugavpils, , Latvia

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Site 406

Jēkabpils, , Latvia

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Site 401

Ogre, , Latvia

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Site 402

Riga, , Latvia

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Site 405

Riga, , Latvia

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Site 404

Tukums, , Latvia

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Site 502

Alytus, , Lithuania

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Site 503

Kaunas, , Lithuania

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Site 506

Kaunas, , Lithuania

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Site 505

Klaipėda, , Lithuania

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Site 507

Klaipėda, , Lithuania

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Site 508

Palanga, , Lithuania

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Site 504

Šiauliai, , Lithuania

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Site 501

Vilnius, , Lithuania

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Site 102

Auckland, , New Zealand

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Site 103

Auckland, , New Zealand

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Site 107

Blenheim, , New Zealand

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Site 101

Christchurch, , New Zealand

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Site 108

Dunedin, , New Zealand

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Site 104

Hamilton, , New Zealand

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Site 111

Hastings, , New Zealand

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Site 106

Nelson, , New Zealand

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Site 110

Newtown, Wellington, , New Zealand

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Site 109

Takapuna, Auckland, , New Zealand

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Site 105

Tauranga, , New Zealand

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Countries

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Australia Estonia Hungary Latvia Lithuania New Zealand

Other Identifiers

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ACTRN012605000777695

Identifier Type: -

Identifier Source: secondary_id

C LF0242780-01 05 02

Identifier Type: -

Identifier Source: org_study_id

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