DyslipidemiaPhase 4NCT01010516
Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia
A Phase 4 study testing High-dose rosuvastatin, Statin plus fenofibrate and Statin plus niacin ER/laropiprant in people with Dyslipidemia, run by University of Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- High-dose rosuvastatin, Statin plus fenofibrate and Statin plus niacin ER/laropiprant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Ioannina Medical School
Ioannina, 45 110
M S Elisaf, MD, +302651007509, egepi@cc.uoi.gr
Moses S Elisaf, MD
About this study
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.
- Conditions
- Dyslipidemia
- Being tested
- High-dose rosuvastatin, Statin plus fenofibrate, Statin plus niacin ER/laropiprant
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose rosuvastatinDrug
40 of rosuvastatin daily
Statin plus fenofibrateDrug
Existing statin plus micronised fenofibrate 200 mg daily
Statin plus niacin ER/laropiprantDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| High-dose rosuvastatin | Active comparator | 40 mg of rosuvastatin Receives: Drug: High-dose rosuvastatin |
| Stain plus fenofibrate | Active comparator | existing statin plus micronized fenofibrate 200 mg Receives: Drug: Statin plus fenofibrate |
| Statin plus niacin ER/laropiprant | Active comparator | 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) Receives: Drug: Statin plus niacin ER/laropiprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in non-HDL-C levels
Measured: 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Investigators
- Moses S Elisaf, MD, Principal investigator, University of Ioannina Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010516
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2009
- First submitted
- 9 Nov 2009
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24618208Kei 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.
PubMed 24379928Kei 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.
PubMed 23600368
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01010516
- Acronym / sponsor ID
- 002
- Conditions
- Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose rosuvastatin | Active comparator | Drug: High-dose rosuvastatin40 mg of rosuvastatin |
| Stain plus fenofibrate | Active comparator | Drug: Statin plus fenofibrateexisting statin plus micronized fenofibrate 200 mg |
| Statin plus niacin ER/laropiprant | Active comparator | Drug: Statin plus niacin ER/laropiprantexisting 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose rosuvastatin40 of rosuvastatin daily | Drug | High-dose rosuvastatin |
| Statin plus fenofibrateExisting statin plus micronised fenofibrate 200 mg daily | Drug | Stain plus fenofibrate |
| Statin plus niacin ER/laropiprantExisting 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 |
Primary outcome
Changes in non-HDL-C levels
Time frame: 6 months after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
- Derived from this study: PubMed 24618208Kei 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.
- Derived from this study: PubMed 24379928Kei 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.
- Derived from this study: PubMed 23600368Kei 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.
- 2nd Department of Internal Medicine, University Hospital of IoanninaLink provided by the sponsor.
- University of Ioannina. GreeceLink provided by the sponsor.
- University Hospital of Ioannina, GreeceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moses S Elisaf, MD principal investigator
University of Ioannina Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-dose rosuvastatin, Statin plus fenofibrate and Statin plus niacin ER/laropiprant in people with Dyslipidemia, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moses S Elisaf, MD (+302651007509, egepi@cc.uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in non-HDL-C levels (time frame: 6 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.