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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00349375
First received: July 6, 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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

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

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

Enrollment: 1040
Study Start Date: November 2005
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 145mg and Simvastatin 20mg
Experimental: 2 Drug: Fenofibrate/Simvastatin
Combination of Fenofibrate and Simvastatin 40 mg
Active Comparator: 3 Drug: Simvastatin
Simvastatin 40 mg

  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 fenofibrate or simvastatin
  • Pregnant or lactating women
  • Contra-indication to fenofibrate or simvastatin
  • 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: NCT00349375

  Show 110 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: NCT00349375     History of Changes
Other Study ID Numbers: C LF0242780-01 05 01
2005-003270-14
Study First Received: July 6, 2006
Last Updated: July 7, 2009

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

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
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 September 19, 2017