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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-dose rosuvastatin

40 mg of rosuvastatin

Group Type ACTIVE_COMPARATOR

High-dose rosuvastatin

Intervention Type DRUG

40 of rosuvastatin daily

Stain plus fenofibrate

existing statin plus micronized fenofibrate 200 mg

Group Type ACTIVE_COMPARATOR

Statin plus fenofibrate

Intervention Type DRUG

Existing statin plus micronised fenofibrate 200 mg daily

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)

Group Type ACTIVE_COMPARATOR

Statin plus niacin ER/laropiprant

Intervention Type DRUG

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)

Interventions

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High-dose rosuvastatin

40 of rosuvastatin daily

Intervention Type DRUG

Statin plus fenofibrate

Existing statin plus micronised fenofibrate 200 mg daily

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No