NCT01010516

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Ioannina · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• First posted: 2009-11-10
• Last updated: 2011-08-10

Locations

1 site across 1 country: Greece