Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

NCT00362934 | Completed Phase 3

• 2 other identifiers: C LF0242780-01 05 032006-000519-21
• Study Type: interventional
• Target: 516
• Locations: 5 countries
• Sites: 68

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 atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia Combined; efficacy combination fenofibrate simvastatin versus atorvastatin

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 (2)

1

EXPERIMENTAL

Drug: fenofibrate / simvastatin

2

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

fenofibrate / simvastatin DRUG

Combination of fenofibrate and simvastatin 20 mg and 40 mg

1

Atorvastatin DRUG

Atorvastatin 10 mg and 20mg

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mixed dyslipidemia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (68)

Site 501

Haskovo, Bulgaria

Location

Site 505

Pleven, Bulgaria

Location

Site 503

Plovdiv, Bulgaria

Location

Site 506

Plovdiv, Bulgaria

Location

Site 500

Sofia, Bulgaria

Location

Site 502

Sofia, Bulgaria

Location

Site 504

Sofia, Bulgaria

Location

Site 507

Sofia, Bulgaria

Location

Site 509

Sofia, Bulgaria

Location

Site 511

Sofia, Bulgaria

Location

Site 508

Varna, Bulgaria

Location

Site 510

Varna, Bulgaria

Location

Site 109

Chrudim, Czechia

Location

Site 117

Havířov, Czechia

Location

Site 101

Olomouc, Czechia

Location

Site 114

Olomouc, Czechia

Location

Site 116

Ostrava, Czechia

Location

Site 107

Pardubice, Czechia

Location

Site 111

Pardubice, Czechia

Location

Site 113

Pilsen, Czechia

Location

Site 100

Prague, Czechia

Location

Site 104

Prague, Czechia

Location

Site 108

Prague, Czechia

Location

Site 110

Prague, Czechia

Location

Site 115

Prague, Czechia

Location

Site 103

Teplice, Czechia

Location

Site 106

Trutnov, Czechia

Location

Site 118

Uničov, Czechia

Location

Site 102

Ústí nad Orlicí, Czechia

Location

Site 203

Berlin, Germany

Location

Site 204

Bochum, Germany

Location

Site 205

Dresden, Germany

Location

Site 206

Görlitz, Germany

Location

Site 202

Hamburg, Germany

Location

Site 208

Karlsruhe, Germany

Location

Site 207

Leipzig, Germany

Location

Site 201

Magdeburg, Germany

Location

Site 209

Nuremberg, Germany

Location

Site 200

Unterschneidheim, Germany

Location

Site 301

Banská Bystrica, Slovakia

Location

Site 307

Bratislava, Slovakia

Location

Site 310

Bratislava, Slovakia

Location

Site 311

Bratislava, Slovakia

Location

Site 312

Bratislava, Slovakia

Location

Site 309

Dolný Kubín, Slovakia

Location

Site 302

Košice, Slovakia

Location

Site 305

Lučenec, Slovakia

Location

Site 306

Nitra, Slovakia

Location

Site 304

Nové Zámky, Slovakia

Location

Site 308

Prešov, Slovakia

Location

Site 303

Vráble, Slovakia

Location

Site 300

Žilina, Slovakia

Location

Site 416

Donetsk, Ukraine

Location

Site 401

Kharkiv, Ukraine

Location

Site 412

Kiev, Ukraine

Location

Site 402

Kyiv, Ukraine

Location

Site 404

Kyiv, Ukraine

Location

Site 408

Kyiv, Ukraine

Location

Site 410

Kyiv, Ukraine

Location

Site 414

Lutsk, Ukraine

Location

Site 406

Lviv, Ukraine

Location

Site 407

Odesa, Ukraine

Location

Site 409

Odesa, Ukraine

Location

Site 411

Odesa, Ukraine

Location

Site 405

Simferopol, Ukraine

Location

Site 413

Uzhhorod, Ukraine

Location

Site 400

Vinnitsa, Ukraine

Location

Site 415

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fenofibrate; Simvastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

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 11, 2006
• First Posted: August 15, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

CZ (17); BU (12); SL (13); UA (16); DE (10)