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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

Primary Purpose

Dyslipidemia

Status

Unknown status

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

High-dose rosuvastatin

Statin plus fenofibrate

Statin plus niacin ER/laropiprant

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Ioannina Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

High-dose rosuvastatin

Stain plus fenofibrate

Statin plus niacin ER/laropiprant

Arm Description

40 mg of rosuvastatin

existing statin plus micronized fenofibrate 200 mg

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)

Outcomes

Primary Outcome Measures

Changes in non-HDL-C levels

Secondary Outcome Measures

Full Information

NCT ID

NCT01010516

First Posted

November 9, 2009

Last Updated

August 9, 2011

Sponsor

University of Ioannina

1. Study Identification

Unique Protocol Identification Number

NCT01010516

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Ioannina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-dose rosuvastatin

Arm Type

Active Comparator

Arm Description

40 mg of rosuvastatin

Arm Title

Stain plus fenofibrate

Arm Type

Active Comparator

Arm Description

existing statin plus micronized fenofibrate 200 mg

Arm Title

Statin plus niacin ER/laropiprant

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

High-dose rosuvastatin

Intervention Description

40 of rosuvastatin daily

Intervention Type

Drug

Intervention Name(s)

Statin plus fenofibrate

Intervention Description

Existing statin plus micronised fenofibrate 200 mg daily

Intervention Type

Drug

Intervention Name(s)

Statin plus niacin ER/laropiprant

Intervention Description

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)

Primary Outcome Measure Information:

Title

Changes in non-HDL-C levels

Time Frame

6 months after treatment initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moses S Elisaf, MD

Phone

+302651007509

egepi@cc.uoi.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moses S Elisaf, MD

Organizational Affiliation

University of Ioannina Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ioannina Medical School

City

Ioannina

ZIP/Postal Code

45 110

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M S Elisaf, MD

Phone

+302651007509

egepi@cc.uoi.gr

First Name & Middle Initial & Last Name & Degree

Moses S Elisaf, MD

First Name & Middle Initial & Last Name & Degree

Evangelos N Liberopoulos, MD

First Name & Middle Initial & Last Name & Degree

Anastazia Kei, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24618208

Citation

Kei A, Tellis C, Liberopoulos E, Tselepis A, Elisaf M. Effect of switch to the highest dose of rosuvastatin versus add-on-statin fenofibrate versus add-on-statin nicotinic acid/laropiprant on oxidative stress markers in patients with mixed dyslipidemia. Cardiovasc Ther. 2014 Aug;32(4):139-46. doi: 10.1111/1755-5922.12072.

Results Reference

derived

PubMed Identifier

24379928

Citation

Kei A, Liberopoulos E, Elisaf M. Effect of hypolipidemic treatment on glycemic profile in patients with mixed dyslipidemia. World J Diabetes. 2013 Dec 15;4(6):365-71. doi: 10.4239/wjd.v4.i6.365.

Results Reference

derived

PubMed Identifier

23600368

Citation

Kei A, Liberopoulos E, Tellis K, Rizzo M, Elisaf M, Tselepis A. Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial. Eur J Clin Invest. 2013 Jul;43(7):698-707. doi: 10.1111/eci.12095. Epub 2013 Apr 20.

Results Reference

derived

Links:

URL

http://www.bpath.gr

Description

2nd Department of Internal Medicine, University Hospital of Ioannina

URL

http://www.uoi.gr

Description

University of Ioannina. Greece

URL

http://www.uhi.gr

Description

University Hospital of Ioannina, Greece

Learn more about this trial

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

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