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Comparison of Lipid-Lowering Strategies in Mixed Hyperlipidemia
NCT01010516Phase 4
Key facts
- Status
- Unknown
- Start
- Oct 2009
- Primary completion
- Dec 2011
- Countries
- 1
- Sponsor
- University of Ioannina
- Modality
- Orthosteric Ligands
- Conditions
- mixed hyperlipidemia
01
Overview
Phase 4, randomised, open-label trial in mixed hyperlipidemia comparing High-dose rosuvastatin, Statin plus fenofibrate and Statin plus niacin ER/laropiprant (3 arms). Primary endpoint: Changes in non-HDL-C levels at 6 months. Status: unknown.
02
Design
3 arms- Study design
- RandomizedOpen-label
High-dose rosuvastatin
40 mg of rosuvastatin daily
Statin plus fenofibrate
Existing statin plus micronized fenofibrate 200 mg daily
Statin plus niacin ER/laropiprant
Existing statin plus extended-release niacin/laropiprant (1 g/day titrated to 2 g/day)
03
Who it enrols
Patients with mixed hyperlipidemia who have non-HDL-C above target after 3 months of conventional statin therapy. Excludes patients with known CVD, severe hypertriglyceridemia, renal or liver disease.
04
Endpoints
Primary
Changes in non-HDL-C levels
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