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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratoires S.M.B.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

26 Jun 2025 → ongoing

Decision date (initial)

2025-02-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Laboratoires S.M.B.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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)

Secondary objectives 1

1. To assess the efficacy and describe the safety of the fixed dose combination of rosuvastatin 20 mg and fenofibrate 160 mg during 12 weeks of treatment.

Conditions and MedDRA coding

Dyslipidaemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or female over 18 years old (18 years inclusive)
2. Treated with Pravafenix® for at least 3 months for mixed dyslipidemia
3. 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.
4. LDL-C • ≥ 55 mg/dL (for very-high risk) • ≥ 70 mg/dL (for high risk)
5. Able to comply with all trial procedures
6. Provide a written informed consent to participate in the clinical trial indicated by a personal signature and date on the participant informed consent form
7. 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 19

1. TG > 300 mg/dl
2. Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed CPK elevation > 5X ULN under statin and/or fibrates treatment
3. Moderate to severe renal impairment (defined as eGFR < 60 ml/min
4. 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)
5. Gallbladder disease
6. Chronic or acute pancreatitis
7. Uncontrolled diabetes with HbA1c > 8.5%
8. Interstitial lung disease
9. 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)
10. Current or foreseen use of any medication as detailed in the section 6.8
11. Use of all contraindicated medicines for both Rosuvastatin/Fenofibrate and Pravafenix (according to SmPCs)
12. Known history of alcohol abuse according to medical history
13. Hypersensitivity to the active substances or to any of the excipients
14. Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen
15. Participation in any other clinical trial within 3 months before the screening visit
16. Pregnancy and breast feeding
17. Evidence of any other unstable or untreated clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease
18. Current or history of cancer within the past 5 years
19. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean percent change from baseline (V2) to week 12 (V4) in Low-Density Lipoprotein (LDL) cholesterol.

Secondary endpoints 10

1. Mean percent change from baseline (V2) to week 12 (V4) in non-High-Density Lipoprotein (non-HDL) cholesterol.
2. Mean percent change from baseline (V2) to week 12 (V4) in HDL cholesterol.
3. Mean percent change from baseline (V2) to week 12 (V4) in Triglycerides.
4. Mean percent change from baseline (V2) to week 12 (V4) in Total cholesterol.
5. Mean percent change from baseline (V2) to week 12 (V4) in Apolipoprotein B (ApoB).
6. Percentage of participants who achieve LDL-C < 55 mg/dL (for very-high risk) or < 70 mg/dL (for high risk).
7. Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).
8. Adverse events of special interest: myopathy, rhabdomyolysis.
9. Absolute Change from baseline in laboratory data.
10. Withdrawal rate

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratoires S.M.B.

Sponsor organisation

Laboratoires S.M.B.

Address

Rue De La Pastorale 26-28

City

Molenbeek-Saint-Jean

Postcode

1080

Country

Belgium

Scientific contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Public contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Third parties 6

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications