The efficacy and safety of a medicine containing the active substance rosuvastati

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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