Patients with primary hypercholesterolemia and mixed dyslipidemia (type IIb) MedDRA version: 14.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861 MedDRA version: 14.1 Level: LLT Classification code 10071235 Term: Combined hyperlipidemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Sorvasta
Pharmaceutical Form: Film-coated tablet
Trade Name: Sorvasta
Pharmaceutical Form: Film-coated tablet
Trade Name: Sorvasta
Pharmaceutical Form: Film-coated tablet
Trade Name: So
Sponsors
Krka, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to establish the efficacy and safety of Sorvasta in wide populations of patients with primary hypercholesterolemia and mixed dyslipidemia (type IIb) (patients with high absolute risk for cardiovascular diseases in primary and secondary prevention) with emphasis on placement of additional strengths 15 mg and 30 mg in clinical practice. ;Secondary Objective: To demonstrate linear association between doses and reduction of LDL-c. To compare the differences between group treated according to usual clinical practise (standard titration: 10 mg – 20 mg – 40 mg) and a group treated according to alternative scheme: 15 mg – 30 mg – 40 mg. To evaluate percentage change in HDL-c, TC and TG, from baseline at all time points (4, 8, 12 weeks). To evaluate percentage of patients achieving the 2011 ESC/EAS guidelines LDL-c goal at all time points (4, 8, 12 weeks). To quantify the rate of adverse reactions associated with treatment. ;Primary end point(s): • To evaluate efficacy of Sorvasta in achieving 2011 ESC/EAS guidelines target LDL-c levels in patients with hyperlipidemia. 2011 ESC/EAS guidelines LDL-c goals: 1.8, 2.5 or 3.0 mmol/l, depending on risk category or a = 50% reduction from baseline LDL-c when target lipid level could not be reached for very high risk patients.;Timepoint(s) of evaluation of this end point: 4, 8, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To demonstrate linear association between doses and reduction of LDL-c. • To compare the differences between group treated according to usual clinical practice (standard titration: 10 mg – 20 mg – 40 mg) and a group treated according to alternative scheme: 15 mg – 30 mg – 40 mg. • To evaluate percentage change in HDL-c, TC and TG, from baseline at all time points (4, 8, 12 weeks). • To evaluate percentage of patients achieving the 2011 ESC/EAS guidelines LDL-c goal at all time points (4, 8, 12 weeks). • To quantify the rate of adverse reactions associated with treatment. ;Timepoint(s) of evaluation of this end point: 4, 8, 12 weeks | — |
Countries
Croatia, Czech Republic, Hungary, Romania, Russian Federation, Slovenia, Ukraine
Contacts
Public ContactClinical Trials Information
Krka, d.d., Novo mesto
Outcome results
None listed