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Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00362934
First received: August 11, 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 atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Condition Intervention Phase
Hyperlipidemia Drug: fenofibrate / simvastatin Drug: Atorvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin 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 ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 12 weeks ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline to 12 weeks of treatment in Triglycerides [ Time Frame: 24 weeks ]
  • Percent change from baseline to 12 weeks of treatment in HDL-C [ Time Frame: 24 weeks ]
  • Percent change from baseline to 12 weeks of treatment in LDL-C [ Time Frame: 24 weeks ]

Enrollment: 516
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: fenofibrate / simvastatin
Combination of fenofibrate and simvastatin 20 mg and 40 mg
Active Comparator: 2 Drug: Atorvastatin
Atorvastatin 10 mg and 20mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362934

  Show 68 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Martine Guy, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00362934     History of Changes
Other Study ID Numbers: C LF0242780-01 05 03
2006-000519-21
Study First Received: August 11, 2006
Last Updated: July 7, 2009

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

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin Calcium
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 27, 2017