Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
Information source: University of Ioannina
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: High-dose rosuvastatin (Drug); Statin plus fenofibrate (Drug); Statin plus niacin ER/laropiprant (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Ioannina Official(s) and/or principal investigator(s):
Moses S Elisaf, MD, Principal Investigator, Affiliation: University of Ioannina Medical School
Overall contact:
Moses S Elisaf, MD, Phone: +302651007509, Email: egepi@cc.uoi.gr
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in non-HDL-C levels
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Moses S Elisaf, MD, Phone: +302651007509, Email: egepi@cc.uoi.gr
University of Ioannina Medical School, Ioannina 45 110, Greece; Recruiting
M S Elisaf, MD, Phone: +302651007509, Email: egepi@cc.uoi.gr
Moses S Elisaf, MD, Principal Investigator
Evangelos N Liberopoulos, MD, Sub-Investigator
Anastazia Kei, MD, Sub-Investigator
Additional Information
2nd Department of Internal Medicine, University Hospital of Ioannina University of Ioannina. Greece University Hospital of Ioannina, Greece
Starting date: October 2009
Last updated: August 9, 2011
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