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OpenTrials
Completed

NCT Number: NCT00349375

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 008, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenofibrate/Simvastatin

Drug

Combination of Fenofibrate 145mg and Simvastatin 20mg

simvastatin

Drug

Simvastatin 40 mg

Primary outcomes

  1. Percent change from baseline to 24 weeks of treatment in Triglycerides

    Time frame: 12 weeks

  2. Percent change from baseline to 24 weeks of treatment in HDL-C

    Time frame: 12 weeks

  3. Percent change from baseline to 24 weeks of treatment in LDL-C

    Time frame: 12 weeks

Secondary outcomes

  1. Percent change from baseline to 24 weeks of treatment in Triglycerides

    Time frame: 24 weeks

  2. Percent change from baseline to 24 weeks of treatment in HDL-C

    Time frame: 24 weeks

  3. Percent change from baseline to 24 weeks of treatment in LDL-C

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Active Comparator, 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 Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 20 mg Simvastatin Alone

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 7, 2006
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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