Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362206
First received: August 8, 2006
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: Fenofibrate/Simvastatin
Drug: Pravastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin Alone

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 423
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 20mg
Experimental: 2 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Active Comparator: 3 Drug: Pravastatin
Pravastatin 40 mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mixed dyslipidemia

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362206

  Hide Study Locations
Locations
Greece
Site 40
Athens, Greece
Site 39
Ioannina, Greece
Site 41
Thessaloniki, Greece
Israel
Site 37
Beer Yaakov, Israel
Site 19
Haifa, Israel
Site 22
Holon, Israel
Site 18
Jerusalem, Israel
Site 38
Kfar Saba, Israel
Site 21
Ramat Gan, Israel
Site 17
Ramat Gan, Israel
Site 20
Rechovot, Israel
Site 24
Safed, Israel
Site 23
Tel-Aviv, Israel
Romania
Site 5
Arad, Romania
Site 7
Bacau, Romania
Site 1
Bucuresti, Romania
Site 6
Cluj-Napoca, Romania
Site 4
Oradea, Romania
Site 3
Ploiesti, Romania
Site 2
Targu Mures, Romania
Russian Federation
Site 27
Barnaul, Russian Federation
Site 31
Kemerovo, Russian Federation
Site 32
Krasnoyarsk, Russian Federation
Site 25
Moscow, Russian Federation
Site 28
Novosibirsk, Russian Federation
Site 26
Smolensk, Russian Federation
Site 29
St. Petersburg, Russian Federation
Site 30
Voronezh, Russian Federation
South Africa
Site 10
Alberton, South Africa
Site 9
Bloemfontein, South Africa
Site 14
Cape Town, South Africa
Site 35
Durban, South Africa
Site 33
Hillcrest, South Africa
Site 34
Kempton Park, South Africa
Site 16
Komatipoort, South Africa
Site 13
Krugersdorp, South Africa
Site 11
Parow, South Africa
Site 12
Port Elizabeth, South Africa
Site 8
Pretoria, South Africa
Site 36
Umkomaas, South Africa
Site 15
Worcester, South Africa
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362206     History of Changes
Other Study ID Numbers: C LF0242780-01 05 04, 2006-000515-15
Study First Received: August 8, 2006
Last Updated: July 7, 2009
Health Authority: Greece: National Organization of Medicines
Israel: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council

Keywords provided by Solvay Pharmaceuticals:
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin
Hyperlipidemia Combined

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Simvastatin
Pravastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 21, 2014