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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Ioannina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT01010516
First received: November 9, 2009
Last updated: August 9, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: High-dose rosuvastatin
Drug: Statin plus fenofibrate
Drug: Statin plus niacin ER/laropiprant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Changes in non-HDL-C levels [ Time Frame: 6 months after treatment initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010516

Contacts
Contact: Moses S Elisaf, MD +302651007509 egepi@cc.uoi.gr

Locations
Greece
University of Ioannina Medical School Recruiting
Ioannina, Greece, 45 110
Contact: M S Elisaf, MD    +302651007509    egepi@cc.uoi.gr   
Principal Investigator: Moses S Elisaf, MD         
Sub-Investigator: Evangelos N Liberopoulos, MD         
Sub-Investigator: Anastazia Kei, MD         
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Moses S Elisaf, MD University of Ioannina Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Moses Elisaf, University of Ioannina Medical School
ClinicalTrials.gov Identifier: NCT01010516     History of Changes
Other Study ID Numbers: 002
Study First Received: November 9, 2009
Last Updated: August 9, 2011
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Niacin
Fenofibrate
Rosuvastatin
Nicotinic Acids
Niacinamide
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014