EUCTR2014-003213-29-PL进行中（未招募）不适用
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.
SciencePharma spólka z ograniczona odpowiedzialnoscia sp. j.0 个研究点开始时间: 2014年11月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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