Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

NCT ID: NCT00349375

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

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

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 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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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 145mg and Simvastatin 20mg

2

Group Type EXPERIMENTAL

Fenofibrate/Simvastatin

Intervention Type DRUG

Combination of Fenofibrate and Simvastatin 40 mg

3

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 40 mg

Interventions

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Fenofibrate/Simvastatin

Combination of Fenofibrate 145mg and Simvastatin 20mg

Intervention Type DRUG

Fenofibrate/Simvastatin

Combination of Fenofibrate and Simvastatin 40 mg

Intervention Type DRUG

Simvastatin

Simvastatin 40 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mixed dyslipidemia

Exclusion Criteria

* 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 008

Brno, , Czechia

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Site 009

Brno, , Czechia

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Site 010

Brno, , Czechia

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Site 015

Hradisk, , Czechia

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Site 019

Karlovy Vary, , Czechia

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Site 014

Kladno, , Czechia

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Site 005

Nymburk, , Czechia

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Site 012

Olomouc, , Czechia

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Site 013

Olomouc, , Czechia

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Site 007

Pilsen, , Czechia

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Site 018

Pilsen, , Czechia

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Site 001

Prague, , Czechia

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Site 002

Prague, , Czechia

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Site 003

Prague, , Czechia

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Site 004

Prague, , Czechia

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Site 016

Příbram, , Czechia

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Site 017

Příbram, , Czechia

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Site 011

Slaný, , Czechia

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Site 006

Tábor, , Czechia

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Site 201

Copenhagen, , Denmark

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Site 205

Copenhagen, , Denmark

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Site 203

Hvidovre, , Denmark

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Site 302

Bouliac, , France

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Site 314

Briollay, , France

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Site 318

Corsept, , France

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Site 301

Dijon, , France

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Site 317

La Montagne, , France

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Site 321

Le Mesnil En Valee, , France

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Site 316

Loudon, , France

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Site 308

Mont-de-Marsan, , France

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Site 312

Mûrs-Erigné, , France

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Site 310

Nantes, , France

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Site 304

Niort, , France

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Site 319

Orvault, , France

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Site 306

Paris, , France

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Site 305

Pouilly-en-Auxois, , France

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Site 307

Rouen, , France

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Site 311

Rouen, , France

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Site 303

Saint-Justin, , France

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Site 315

Thouars, , France

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Site 309

Vieux-Condé, , France

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Site 313

Vihiers, , France

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Site 320

Vue, , France

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Site 109

Deidesheim, , Germany

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Site 108

Frankfurt, , Germany

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Site 101

Freiburg im Breisgau, , Germany

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Site 111

Hamburg, , Germany

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Site 103

Hanover, , Germany

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Site 104

Ilvesheim, , Germany

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Site 110

Kassel, , Germany

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Site 106

Mannheim, , Germany

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Site 114

München, , Germany

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Site 113

Neu-Anspach, , Germany

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Site 105

Offenbach, , Germany

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Site 107

Offenbach, , Germany

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Site 115

Paderborn Kernstadt, , Germany

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Site 102

Rodgau, , Germany

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Site 112

Wermsdorf, , Germany

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Site 406

Békéscsaba, , Hungary

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Site 401

Budapest, , Hungary

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Site 411

Budapest, , Hungary

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Site 412

Budapest, , Hungary

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Site 405

Debrecen, , Hungary

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Site 402

Gyöngyös, , Hungary

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Site 409

Gyula, , Hungary

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Site 410

Kecskemét, , Hungary

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Site 404

Miskolc, , Hungary

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Site 413

Mosonmagyaróvár, , Hungary

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Site 407

Orosháza, , Hungary

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Site 408

Szeged, , Hungary

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Site 403

Szolnok, , Hungary

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Site 511

's-Hertogenbosch, , Netherlands

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Site 508

Breda, , Netherlands

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Site 509

De Bilt, , Netherlands

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Site 502

Eindhoven, , Netherlands

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Site 514

Eindhoven, , Netherlands

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Site 503

Groningen, , Netherlands

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Site 512

Hengelo, , Netherlands

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Site 506

Leiden, , Netherlands

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Site 507

Nijmegen, , Netherlands

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Site 501

Rotterdam, , Netherlands

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Site 513

Tiel, , Netherlands

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Site 510

Utrecht, , Netherlands

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Site 505

Velp, , Netherlands

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Site 504

Zoetermeer, , Netherlands

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Site 606

Chrzanów, , Poland

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Gdansk, , Poland

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Site 603

Katowice, , Poland

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Site 609

Sopot, , Poland

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Warsaw, , Poland

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Site 607

Warsaw, , Poland

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Site 608

Warsaw, , Poland

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Site 605

Wroclaw, , Poland

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Site 610

Wroclaw, , Poland

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Site 604

Zabrze, , Poland

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Site 701

Dnipropetrovsk, , Ukraine

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Site 702

Dnipropetrovsk, , Ukraine

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Site 709

Dnipropetrovsk, , Ukraine

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Site 712

Donetsk, , Ukraine

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Site 703

Kharkiv, , Ukraine

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Site 705

Kharkiv, , Ukraine

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Site 711

Kharkiv, , Ukraine

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Site 704

Kyiv, , Ukraine

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Site 706

Kyiv, , Ukraine

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Site 707

Kyiv, , Ukraine

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Site 708

Kyiv, , Ukraine

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Site 715

Kyiv, , Ukraine

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Site 713

Luhansk, , Ukraine

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Site 714

Odesa, , Ukraine

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Site 710

Zaporizhya, , Ukraine

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Countries

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Czechia Denmark France Germany Hungary Netherlands Poland Ukraine

Other Identifiers

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2005-003270-14

Identifier Type: -

Identifier Source: secondary_id

C LF0242780-01 05 01

Identifier Type: -

Identifier Source: org_study_id

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