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

August 9, 2011 updated by: University of Ioannina
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Moses S Elisaf, MD
  • Phone Number: +302651007509
  • Email: egepi@cc.uoi.gr

Study Locations

  • Greece
      • Ioannina, Greece, 45 110
        • Recruiting
        • University of Ioannina Medical School
        • Contact:
        • Principal Investigator:
          • Moses S Elisaf, MD
        • Sub-Investigator:
          • Evangelos N Liberopoulos, MD
        • Sub-Investigator:
          • Anastazia Kei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High-dose rosuvastatin
40 mg of rosuvastatin
Drug: High-dose rosuvastatin
40 of rosuvastatin daily
ACTIVE_COMPARATOR: Stain plus fenofibrate
existing statin plus micronized fenofibrate 200 mg
Drug: Statin plus fenofibrate
Existing statin plus micronised fenofibrate 200 mg daily
ACTIVE_COMPARATOR: 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in non-HDL-C levels
Time Frame: 6 months after treatment initiation
6 months after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Investigators

  • Principal Investigator: Moses S Elisaf, MD, University of Ioannina Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyslipidemia

Clinical Trials on High-dose rosuvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe