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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Ioannina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT01010516
First received: November 9, 2009
Last updated: August 9, 2011
Last verified: November 2009

November 9, 2009
August 9, 2011
October 2009
December 2011   (final data collection date for primary outcome measure)
Changes in non-HDL-C levels [ Time Frame: 6 months after treatment initiation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010516 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyslipidemia
  • Drug: High-dose rosuvastatin
    40 of rosuvastatin daily
  • Drug: Statin plus fenofibrate
    Existing statin plus micronised fenofibrate 200 mg daily
  • 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)
  • Active Comparator: High-dose rosuvastatin
    40 mg of rosuvastatin
    Intervention: Drug: High-dose rosuvastatin
  • Active Comparator: Stain plus fenofibrate
    existing statin plus micronized fenofibrate 200 mg
    Intervention: Drug: Statin plus fenofibrate
  • 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)
    Intervention: Drug: Statin plus niacin ER/laropiprant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Moses S Elisaf, MD +302651007509 egepi@cc.uoi.gr
Greece
 
NCT01010516
002
No
Prof Moses Elisaf, University of Ioannina Medical School
University of Ioannina
Not Provided
Principal Investigator: Moses S Elisaf, MD University of Ioannina Medical School
University of Ioannina
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP