Rosuvastatin; Fenofibrate for Dyslipidaemia

Inclusion criteria

• {"criterion_text":"- Male or female over 18 years old (18 years inclusive)\n- Treated with Pravafenix® for at least 3 months for mixed dyslipidemia\n- 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.\n- LDL-C • ≥ 55 mg/dL (for very-high risk) • ≥ 70 mg/dL (for high risk)\n- Able to comply with all trial procedures\n- Provide a written informed consent to participate in the clinical trial indicated by a personal signature and date on the participant informed consent form\n- 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."}

Exclusion criteria

• {"criterion_text":"- TG > 300 mg/dl\n- Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed CPK elevation > 5X ULN under statin and/or fibrates treatment\n- Moderate to severe renal impairment (defined as eGFR < 60 ml/min\n- 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)\n- Gallbladder disease\n- Chronic or acute pancreatitis\n- Uncontrolled diabetes with HbA1c > 8.5%\n- Interstitial lung disease\n- 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)\n- Current or foreseen use of any medication as detailed in the section 6.8\n- Use of all contraindicated medicines for both Rosuvastatin/Fenofibrate and Pravafenix (according to SmPCs)\n- Known history of alcohol abuse according to medical history\n- Hypersensitivity to the active substances or to any of the excipients\n- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen\n- Participation in any other clinical trial within 3 months before the screening visit\n- Pregnancy and breast feeding\n- Evidence of any other unstable or untreated clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease\n- Current or history of cancer within the past 5 years\n- 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"}

Primary endpoints

• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in Low-Density Lipoprotein (LDL) cholesterol.","definition_or_measurement_approach":"Mean percent change in LDL cholesterol from baseline visit (V2) to week 12 (V4); measured as percent change from baseline to V4."}

Secondary endpoints

• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in non-High-Density Lipoprotein (non-HDL) cholesterol.","definition_or_measurement_approach":"Mean percent change from baseline (V2) to week 12 (V4) in non-HDL cholesterol."}
• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in HDL cholesterol.","definition_or_measurement_approach":"Mean percent change from baseline (V2) to week 12 (V4) in HDL cholesterol."}
• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in Triglycerides.","definition_or_measurement_approach":"Mean percent change from baseline (V2) to week 12 (V4) in triglycerides."}
• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in Total cholesterol.","definition_or_measurement_approach":"Mean percent change from baseline (V2) to week 12 (V4) in total cholesterol."}
• {"endpoint_text":"- Mean percent change from baseline (V2) to week 12 (V4) in Apolipoprotein B (ApoB).","definition_or_measurement_approach":"Mean percent change from baseline (V2) to week 12 (V4) in ApoB."}
• {"endpoint_text":"- Percentage of participants who achieve LDL-C < 55 mg/dL (for very-high risk) or < 70 mg/dL (for high risk).","definition_or_measurement_approach":"Proportion of participants achieving LDL-C thresholds (<55 mg/dL for very-high risk; <70 mg/dL for high risk) assessed at week 12 (V4)."}
• {"endpoint_text":"- Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).","definition_or_measurement_approach":"Incidence rates of AEs, SAEs and SUSARs collected throughout the study period."}
• {"endpoint_text":"- Adverse events of special interest: myopathy, rhabdomyolysis.","definition_or_measurement_approach":"Incidence of specified AEs of special interest (myopathy, rhabdomyolysis) during treatment and follow-up."}
• {"endpoint_text":"- Absolute Change from baseline in laboratory data.","definition_or_measurement_approach":"Absolute change from baseline for laboratory parameters measured during the study."}
• {"endpoint_text":"- Withdrawal rate","definition_or_measurement_approach":"Proportion of participants who withdraw from the study prior to completion."}

Greece

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

259

Number Of Sites

7

Number Of Participants

150

Primary sponsor

Full Name

Laboratoires S.M.B.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Pharmassist Ltd.

Responsibilities

[1,12,2,5]

Name

Soladis Clinical Studies

Responsibilities

[10,11,3,6,7]

Name

Cerba Research

Responsibilities

[4]

Third parties

• {"country":"Greece","full_name":"Pharmassist Ltd.","duties_or_roles":"[1,12,2,5]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"S.M.B. Technology","duties_or_roles":"[14]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Galephar M/F","duties_or_roles":"[14]","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Soladis Clinical Studies","duties_or_roles":"[10,11,3,6,7]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"[4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"Qplus Consult","duties_or_roles":"[8]","organisation_type":"Pharmaceutical company"}