A multicenter, double-blind, randomized, forced-titration study to compare the efficacy and safety of the combination of 145 mg fenofibrate and 20 or 40 mg simvastatin with atorvastatin monotherapy in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 10 mg atorvastatin alone - N.A.
- Conditions
- Study in patients with mixed dyslipidemia at risk of cardiovascular disease not adequately controlled by 10 mg atorvastatin aloneMedDRA version: 8.1Level: LLTClassification code 10027763
- Registration Number
- EUCTR2006-000519-21-CZ
- Lead Sponsor
- FOURNIER LABORATORIES IRELAND Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3650
A patient will be eligible for study participation if he/she meets the following criteria at the inclusion visit, V1 (these criteria also apply for patients already treated with stable doses of 10 mg atorvastatin):
1. Either gender
2. = 18 and < 75 years
3. Presenting with CHD or CHD risk equivalent per NCEP ATPIII (excluding diabetes)
in whom 10-year risk for CHD is > 20%
OR
with no CHD but multiple = 2 risk factors
4. Having signed a written informed consent
5. Patient must be willing to observe the AHA Step I or similar Diet recommended throughout the study.
6. Presenting at inclusion (V1) with mixed (type IIb) dyslipidemia documented in the medical file and defined as follows on fasting lipid lab results:
• For patients not treated with lipid lowering drugs at the time of blood sampling: TG = 200 mg/dL (= 2.28 mmol/L) and TC = 240 mg/dL (= 6.20 mmol/L) or LDL-C = 130 mg/dL (= 3.36 mmol/L) or non-HDL-C = 160 mg/dL (=4.13 mmol/L)
• For patients treated with lipid lowering drugs at the time of blood sampling:
- Patients with CHD or CHD risk equivalent in whom 10-year risk for CHD is > 20%: TG = 150 mg/dL (= 1.71 mmol/L) and LDL-C = 100 mg/dL (= 2.58 mmol/L) or Non-HDL-C = 130 mg/dL (= 3.36 mmol/L)
- Patients with multiple = 2 risk factors: TG = 150 mg/dL (= 1.71 mmol/L) and LDL-C = 130 mg/dL (= 3.36 mmol/L) or non-HDL-C = 160 mg/dL (= 4.13 mmol/L)
If there are no fasting lipid lab results available in the patient’s medical file at V1, a fasting lipid lab test must be performed in a local lab before entering the patient in the 10 mg atorvastatin run-in phase and the results have to confirm the diagnosis of mixed dyslipidemia as defined above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A patient will not be included in the study if he/she meets any of the following clinical criteria at the inclusion visit, V1.
1. Known hypersensitivity to fibrates, atorvastatin or simvastatin or known
photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts oil and soy lecithin
2. Pregnant or lactating women
3. Unable or unwilling to comply with the protocol and the recommended diet
4. Likely to withdraw from the study before its completion
5. Having received an investigational drug or investigational vaccine in the last 30 days before date of inclusion, or still participating in such a trial at V1
Associated diseases or condition
6. Known type 1 or type 2 diabetes
7. Known active or chronic hepatobiliary or liver diseases
8. Known cholelithiasis (except in case of cholecystectomy)
9. Current chronic pancreatitis or identified risk or past history of acute pancreatitis
10.Known current alcoholism or alcohol intake greater than 21 units per week
11.Past medical history of myositis, myopathy or rhabdomyolysis
12.Known abnormal thyroid hormone levels (clinically euthyroid patients on stable replacement doses of thyroid hormone are eligible for inclusion)
13.Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
14.Known renal failure or renal dysfunction
15.Congestive heart failure NYHA Class III or IV (class III marked limitation of physical activity, class IV inability to carry out any physical activity without discomfort)
16.Uncontrolled cardiac arrhythmias
17.Myocardial infarction, coronary bypass surgery or angioplasty within 3 months of inclusion in the study
18.Unstable or severe peripheral artery disease within 3 months of inclusion in the study
19. Unstable angina pectoris within 3 months of inclusion in the study
20. Any other severe pathology such as cancer or mental illness or degenerative disease that would limit study evaluation or participation
Concomitant medications:
For prohibited concomitant medication ongoing at V1, treatment must be stopped, if clinically appropriate. If not clinically appropriate, the patient should not be included in the study. All other concomitant medications are allowed and will be recorded on the patient’s CRF. Any change in concomitant medications (initiation of a new therapy, dosage change in ongoing therapy, stop of treatment…) will be recorded on the concomitant medication from in the CRF.
Treatment with lipid-lowering drugs other than fibrates must be stopped at least 4 weeks prior to baseline blood sample. Fibrates must be stopped at least 6 weeks prior to baseline blood sample.
21.Treated with lipid-lowering drugs (statin, ezetimibe, fibrate, niacin…) other than atorvastatin 10 mg. Patients receiving regular maintenance doses below 1g/day of OTC lipid-lowering medications (e.g. fish oils, omega-3 fatty acids supplements…) or OTC products (e.g. psyllium, fiber-based preparations and phytosterols) can be enrolled provided they are on stable dose for at least 4 weeks before randomisation and agree to take the same preparation at an unchanged dose for the study duration.
22.Treated with cyclosporin A, anti-vitamin K, long term systemic corticosteroids (unless the corticosteroids are for replacement therapy to treat pituitary adrenal disease and patients were treated with a stable regimen for at least 4 weeks before baseline blood sample),
23.Treated with CYP3A4 inhibitors o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method