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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

Information source: University of Ioannina
ClinicalTrials.gov processed this data on August 23, 2015
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

Page last updated: August 23, 2015

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