Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

NCT ID: NCT00362934

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

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

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 compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin 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 20 mg and 40 mg

2

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin 10 mg and 20mg

Interventions

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fenofibrate / simvastatin

Combination of fenofibrate and simvastatin 20 mg and 40 mg

Intervention Type DRUG

Atorvastatin

Atorvastatin 10 mg and 20mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mixed dyslipidemia.

Exclusion Criteria

* Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin or atorvastatin
* 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 501

Haskovo, , Bulgaria

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Site 505

Pleven, , Bulgaria

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Site 503

Plovdiv, , Bulgaria

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Site 506

Plovdiv, , Bulgaria

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Site 500

Sofia, , Bulgaria

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Site 502

Sofia, , Bulgaria

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Site 504

Sofia, , Bulgaria

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Site 507

Sofia, , Bulgaria

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Site 509

Sofia, , Bulgaria

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Site 511

Sofia, , Bulgaria

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Site 508

Varna, , Bulgaria

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Site 510

Varna, , Bulgaria

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Site 109

Chrudim, , Czechia

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Site 117

Havířov, , Czechia

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Site 101

Olomouc, , Czechia

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Site 114

Olomouc, , Czechia

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Site 116

Ostrava, , Czechia

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Site 107

Pardubice, , Czechia

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Site 111

Pardubice, , Czechia

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Site 113

Pilsen, , Czechia

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Site 100

Prague, , Czechia

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Site 104

Prague, , Czechia

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Site 108

Prague, , Czechia

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Site 110

Prague, , Czechia

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Site 115

Prague, , Czechia

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Site 103

Teplice, , Czechia

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Site 106

Trutnov, , Czechia

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Site 118

Uničov, , Czechia

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Site 102

Ústí nad Orlicí, , Czechia

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Site 203

Berlin, , Germany

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Site 204

Bochum, , Germany

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Site 205

Dresden, , Germany

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Site 206

Görlitz, , Germany

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Site 202

Hamburg, , Germany

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Site 208

Karlsruhe, , Germany

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Site 207

Leipzig, , Germany

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Site 201

Magdeburg, , Germany

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Site 209

Nuremberg, , Germany

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Site 200

Unterschneidheim, , Germany

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Site 301

Banská Bystrica, , Slovakia

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Site 307

Bratislava, , Slovakia

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Site 310

Bratislava, , Slovakia

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Site 311

Bratislava, , Slovakia

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Site 312

Bratislava, , Slovakia

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Site 309

Dolný Kubín, , Slovakia

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Site 302

Košice, , Slovakia

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Site 305

Lučenec, , Slovakia

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Site 306

Nitra, , Slovakia

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Site 304

Nové Zámky, , Slovakia

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Site 308

Prešov, , Slovakia

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Site 303

Vráble, , Slovakia

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Site 300

Žilina, , Slovakia

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Site 416

Donetsk, , Ukraine

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Site 401

Kharkiv, , Ukraine

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Site 412

Kiev, , Ukraine

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Site 402

Kyiv, , Ukraine

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Site 404

Kyiv, , Ukraine

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Site 408

Kyiv, , Ukraine

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Site 410

Kyiv, , Ukraine

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Site 414

Lutsk, , Ukraine

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Site 406

Lviv, , Ukraine

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Site 407

Odesa, , Ukraine

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Site 409

Odesa, , Ukraine

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Site 411

Odesa, , Ukraine

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Site 405

Simferopol, , Ukraine

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Site 413

Uzhhorod, , Ukraine

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Site 400

Vinnitsa, , Ukraine

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Site 415

Zaporizhzhya, , Ukraine

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Countries

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Bulgaria Czechia Germany Slovakia Ukraine

Other Identifiers

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2006-000519-21

Identifier Type: -

Identifier Source: secondary_id

C LF0242780-01 05 03

Identifier Type: -

Identifier Source: org_study_id

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