A randomized, multicenter, open-label, two-arm, parallel, phase III study to evaluate the efficacy and safety of nicotinic acid administered in combination with simvastatin for 6 months in comparison to simvastatin therapy alone in inhibiting the progression of atherosclerosis in patients with carotid arteries stenosis and dyslipidemia.

• Conditions: Inhibiting the progression of atherosclerosis in patients with carotid arteries stenosis and dyslipidemia.; MedDRA version: 17.1Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 17.1Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003213-29-PL
• Lead Sponsor: SciencePharma spólka z ograniczona odpowiedzialnoscia sp. j.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-17
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Caucasian men and women aged = 18 years;
2. Stenosis of at least one internal carotid artery (ICA) < 70% assessed by carotid arteries ultrasound;
3. LDL-C level > 100 mg / dL (> 2.5 mmol / L) despite taking simvastatin 20 mg daily or equivalent dose of another statin for at least last 28 days;
4. LDL-C level > 115 mg / dl (> 3 mmol / L) in patients not taking any statin over the last 28 days;
5. Patients capable of understanding and following the study procedures;
6. Signing of Informed Consent Form to participate the study before the qualification procedures begin.

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Known allergy and/or hypersensitivity to nicotinic acid and/or its derivatives and/or to any study product excipients;
2. Known allergy and/or hypersensitivity to simvastatin and/or its derivatives and/or to any study product excipients;
3. Pregnancy or lactation period in females;
4. Stenosis of at least one internal carotid artery (ICA) = 70% assessed by carotid arteries ultrasound;
5. Symptomatic stenosis of any carotid artery, regardless of the stenosis degree;
6. Patients scheduled to undergo invasive treatment of any carotid artery: carotid endarterectomy (CEA) or cartoid artery stenting (CAS);
7. History of previous CEA or CAS of any carotid artery;
8. Hypotension (systolic blood pressure < 100 mmHg at screening and/or at any time within 3 months prior to enrolment);
9. Uncontrolled hypertension – systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg at screening and/or at any time within 3 months prior to enrolment;
10. Unstable angina pectoris;
11. Heart failure (NYHA III-IV);
12. Symptomatic stenosis or symptomatic aortic regurgitation;
13. Renal failure - estimated creatinine clearance < 30 ml/min or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or the need for dialysis;
14. Active liver disease or persistent and unexplained aminotransferases elevations (AST and /or ALT) exceeding the upper limit of normal range;
15. Aminotransferases levels (AST and/or ALT) exceeding > 3 times the upper limit of normal range;
16. Jaudince;
17. Ascites found in physical examination;
18. Active peptic ulcer disease;
19. Gout or uric acid levels above the upper limit of normal range;
20. Primary, hereditaryl, monogenic, homo- or heterozygotic familiar dyslipidemia
21. Triglycerides level > 400 mg/dl (> 4.6 mmol/l);
22. Individual or familiar anamnesis of hereditary muscular system disorders;
23. History of statins- or fibrates-induced muscle toxicity;
24. Inflammatory muscle diseases;
25. Clinical symptoms of myopathy;
26. CK activity exceeds 5 times the upper limit of the normal range;
27. Type 1 diabetes or diabetes mellitus with a known etiology (secondary);
28. The percentage of glycated hemoglobin = 12.0;
29. Free thyroxine (FT4) concentration below the lower limit of normal range;
30. Glaucoma;
31. History of malignant neoplastic disease that has not been in remission for at least 5 years at screening;
32. Taking fibrates, ion exchange resins, or ezetimibe within 90 days prior to enrollment;
33. Systemic administration of following drugs, if it is not possible to stop taking those drugs during study;
• antifungal drugs: fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;
• antibacterial drugs: erythromycin, clarithromycin, telithromycin, fusidic acid;
• antiviral drugs: HIV protease inhibitors (eg. Nelflinawir), kobicystatu, boceprevir, telaprevir;
• medicines used in cardiovascular system diseases: amiodarone, dronedarone, verapamil, ranolazine;
• nefazodone, cyclosporine, danazol, lomitapide;
• vitamin K antagonists (eg. Acenocoumarol, warfarin, phenprocoumon);
• non-investigational medicinal product containing nicotinic acid, nicotinic acid or nicotinamide preparations (vitamin. B3 vitamin. PP) or other nicotinic acid derivatives (eg. hydroxymethylamide of nicotinic acid, inositol hexanicotinate);
• preparations containing polyunsaturated fatty acids, ?-3.
34. Participation in any clinical trial within 90 days prior to enrollment;
35. Severe subjects who are known or suspect

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified