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
Recruitment status was Recruiting
Sponsor:
University of Ioannina
Information provided by:
University of Ioannina
ClinicalTrials.gov Identifier:
NCT01010516
First received: November 9, 2009
Last updated: August 9, 2011
Last verified: November 2009
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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:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
MedlinePlus related topics:
Statins
U.S. FDA Resources
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
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 May 16, 2013