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Study to compare the efficacy and safety of a 12-week administration of two fixed-dose combinations (Rosuvastatin 20 mg and Fenofibrate 160 mg versus Pravafenix®) in patients with mixed dyslipidaemia.
EU CTIS ID: 2024-514289-38-00
What this study is testing
To demonstrate the superiority of the efficacy of the fixed-dose combination of rosuvastatin 20 mg and fenofibrate 160 mg versus Pravafenix®, in high/very high coronary heart disease-risk patients with mixed dyslipidaemia not at goal for Low-Density Lipoprotein Cholesterol (LDL-C ≥70 mg/dl for high-risk patients or ≥55 mg/dl for very high risk patients)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female over 18 years old (18 years inclusive)
- Treated with Pravafenix® for at least 3 months for mixed dyslipidemia
- Participants with high or very high CHD-risk as defined by ESC/EAS guidelines (2019); High risk: People with any of the following: •A calculated SCORE ≥5% and <10% for 10-year risk of fatal cardiovascular disease. •Markedly elevated single risk factors, in particular total cholesterol >8 mmol/L (>310 mg/dL), LDL-C >4.9 mmol/L (>190 mg/dL), or blood pressure ≥180/110 mmHg. •Patients with familial hypercholesterolaemia without other major risk factors. •Patients with diabetes mellitus without target organ damage, or with diabetes mellitus duration ≥10 years or another additional risk factor. Very high risk: People with any of the following: •A calculated SCORE ≥10% for 10-year risk of fatal cardiovascular disease. •Documented atherosclerotic cardiovascular disease, either clinical or unequivocal on imaging. Documented atherosclerotic cardiovascular disease includes previous acute coronary syndrome (myocardial infarction or unstable angina), stable angina, coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery, and other arterial revascularization procedures), stroke and transient ischaemic attack, and peripheral arterial disease. Unequivocally documented atherosclerotic cardiovascular disease on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or atherosclerotic cardiovascular disease scan (multivessel coronary disease with two major epicardial arteries having >50% stenosis), or on carotid ultrasound. •Diabetes mellitus with target organ damage, or at least three major risk factors, or early onset of Type 1 diabetes mellitus of long duration (>20 years). •Familial hypercholesterolaemia with atherosclerotic cardiovascular disease or with another major risk factor.
- LDL-C • ≥ 55 mg/dL (for very-high risk) • ≥ 70 mg/dL (for high risk)
- Able to comply with all trial procedures
- Provide a written informed consent to participate in the clinical trial indicated by a personal signature and date on the participant informed consent form
You likely can't join if
- TG > 300 mg/dl
- Current or foreseen use of any medication as detailed in the section 6.8
- Use of all contraindicated medicines for both Rosuvastatin/Fenofibrate and Pravafenix (according to SmPCs)
- Known history of alcohol abuse according to medical history
- Hypersensitivity to the active substances or to any of the excipients
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen
See the full eligibility criteria
Who can join
- Male or female over 18 years old (18 years inclusive)
- Treated with Pravafenix® for at least 3 months for mixed dyslipidemia
- Participants with high or very high CHD-risk as defined by ESC/EAS guidelines (2019); High risk: People with any of the following: •A calculated SCORE ≥5% and <10% for 10-year risk of fatal cardiovascular disease. •Markedly elevated single risk factors, in particular total cholesterol >8 mmol/L (>310 mg/dL), LDL-C >4.9 mmol/L (>190 mg/dL), or blood pressure ≥180/110 mmHg. •Patients with familial hypercholesterolaemia without other major risk factors. •Patients with diabetes mellitus without target organ damage, or with diabetes mellitus duration ≥10 years or another additional risk factor. Very high risk: People with any of the following: •A calculated SCORE ≥10% for 10-year risk of fatal cardiovascular disease. •Documented atherosclerotic cardiovascular disease, either clinical or unequivocal on imaging. Documented atherosclerotic cardiovascular disease includes previous acute coronary syndrome (myocardial infarction or unstable angina), stable angina, coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery, and other arterial revascularization procedures), stroke and transient ischaemic attack, and peripheral arterial disease. Unequivocally documented atherosclerotic cardiovascular disease on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or atherosclerotic cardiovascular disease scan (multivessel coronary disease with two major epicardial arteries having >50% stenosis), or on carotid ultrasound. •Diabetes mellitus with target organ damage, or at least three major risk factors, or early onset of Type 1 diabetes mellitus of long duration (>20 years). •Familial hypercholesterolaemia with atherosclerotic cardiovascular disease or with another major risk factor.
- LDL-C • ≥ 55 mg/dL (for very-high risk) • ≥ 70 mg/dL (for high risk)
- Able to comply with all trial procedures
- Provide a written informed consent to participate in the clinical trial indicated by a personal signature and date on the participant informed consent form
- If participant is a woman of childbearing potential, participant must use a highly effective contraception from screening visit until the last dose of the trial intervention.
What rules you out
- TG > 300 mg/dl
- Current or foreseen use of any medication as detailed in the section 6.8
- Use of all contraindicated medicines for both Rosuvastatin/Fenofibrate and Pravafenix (according to SmPCs)
- Known history of alcohol abuse according to medical history
- Hypersensitivity to the active substances or to any of the excipients
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen
- Participation in any other clinical trial within 3 months before the screening visit
- Pregnancy and breast feeding
- Evidence of any other unstable or untreated clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease
- Current or history of cancer within the past 5 years
- Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the trial and likely to jeopardize the planned termination of the trial
- Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed CPK elevation > 5X ULN under statin and/or fibrates treatment
- Moderate to severe renal impairment (defined as eGFR < 60 ml/min
- Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (ASAT/SGOT or ALAT/SGPT elevation > 3X ULN)
- Gallbladder disease
- Chronic or acute pancreatitis
- Uncontrolled diabetes with HbA1c > 8.5%
- Interstitial lung disease
- Need for use of any other lipid-regulating drugs than the trial intervention from V2 to V4 (including statins, colestyramine, colestipol, cholestagel, ezetimibe, nicotinic acid, fibrates, n-3 and n-6 fatty acids, cholesteryl ester transfer protein inhibitors, etc)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.