EUCTR2012-004799-21-HU进行中（未招募）1 期
The Efficacy and Safety of ROSUvastatin Dose Titration in the Treatment of PATients with Hyperlipidemia (ROSU-PATH) - ROSU-PATH
KRKA Magyarország Kft., Budapest0 个研究点目标入组 610 人开始时间: 2013年6月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 610
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
- •Patients of both genders with primary hypercholesterolemia or mixed dyslipidemia (type IIb), when the response to diet and other non-pharmacological measures has been inadequate.
- •Age 18 years to 75 years.
- •Written informed consent provided by patients or legally acceptable representative.
- •Absence of hypolipidemic therapy during not less than 4 weeks prior to the 1st visit.
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Serum TG values exceeding 4.5 mmol/l.
- •The aim of the study is to exclude patients with predominant hypertriglyceridemia or with severe combined hyperlipidemia because of their influence on the evaluation of results.
- •TC values exceeding 10 mmol/l.
- •This criterion will be used to exclude from the study patients with severe hypercholesterolemia, including homozygote familial hypercholesterolemia.
- •Secondary hyperlipidemia due to hypothyroidism, nephrotic syndrome, type I diabetes mellitus, obstructive gallbladder, biliary disease, pancreatitis, immunologic abnormalities, or drug induced.
- •Hypersensitivity to rosuvastatin or to any of the excipients.
- •Active liver disease, including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN).
- •Severe renal impairment (creatinine clearance < 30 ml/min or 0.5 ml/s).
- •Statin induced myopathy (an abnormal condition of skeletal muscle characterized by muscle weakness, wasting, and histologic changes within muscle tissue) that can present as myalgia (muscle aches or weakness without creatinine kinase (CK) elevation) or rhabdomyolysis (muscle symptoms with marked CK elevation more than 5 times the upper limits of normal).
- •Treatment with the following drug: cyclosporine, other lipid-lowering medicines (statins, fibrates, nicotinic acid, bile acid exchangers, probucol, ezetimibe).
- •Pregnancy and lactation and childbearing potential in women not using appropriate contraceptive measures.
- •Pathological clinical states that could affect patient’s compliance, or have any impact on patient’s survival rate (malignant diseases, alcohol abuse, medicine addiction, psychiatric diseases).
- •Acute disease state (infections, acute exacerbation of chronic diseases, trauma, surgical intervention) within the period of the past two months.
- •Severe, unstable heart failure.
- •Participation in another clinical trial within thirty days prior to enrolment.
- •Patients who are not able out of any reason to fulfill the requirements of the protocol.
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