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Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT01010516
Recruitment Status : Unknown
Verified November 2009 by University of Ioannina.
Recruitment status was:  Recruiting
First Posted : November 10, 2009
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown what would be the best treatment option for patients with mixed hyperlipidemia who fail to meet their lipid targets with statin monotherapy at conventional does, i.e. high dose rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs conventional statin dose plus extended-release niacin/laropiprant on lipid profile in patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in non-HDL-C levels at 6 months after treatment initiation.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: High-dose rosuvastatin Drug: Statin plus fenofibrate Drug: Statin plus niacin ER/laropiprant Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
Study Start Date : October 2009
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Statins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: High-dose rosuvastatin
40 mg of rosuvastatin
Drug: High-dose rosuvastatin
40 of rosuvastatin daily
Active Comparator: Stain plus fenofibrate
existing statin plus micronized fenofibrate 200 mg
Drug: Statin plus fenofibrate
Existing statin plus micronised fenofibrate 200 mg daily
Active Comparator: Statin plus niacin ER/laropiprant
existing statin plus extended-release niacin/laropiprant (1 g/day for the first month which will be uptitrated to 2 g/day for the next months)
Drug: Statin plus niacin ER/laropiprant
Existing statin plus extended-release niacin/laropiprant (1 g/day for the first month which will be uptitrated to 2 g/day for the next months)


Outcome Measures

Primary Outcome Measures :
  1. Changes in non-HDL-C levels [ Time Frame: 6 months after treatment initiation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-HDL-C above target goal according to NCEP-ATP III after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg

Exclusion Criteria:

  • Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout.
  • Patients with diabetes will be included in the study if they are adequately controlled (HbA1c <7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
  • Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
  • Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010516


Contacts
Contact: Moses S Elisaf, MD +302651007509 egepi@cc.uoi.gr

Locations
Greece
University of Ioannina Medical School Recruiting
Ioannina, Greece, 45 110
Contact: M S Elisaf, MD    +302651007509    egepi@cc.uoi.gr   
Principal Investigator: Moses S Elisaf, MD         
Sub-Investigator: Evangelos N Liberopoulos, MD         
Sub-Investigator: Anastazia Kei, MD         
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Moses S Elisaf, MD University of Ioannina Medical School
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Moses Elisaf, University of Ioannina Medical School
ClinicalTrials.gov Identifier: NCT01010516     History of Changes
Other Study ID Numbers: 002
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipidemia, Familial Combined
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Fenofibrate
Niacin
Niacinamide
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs