None listed
Conditions
Interventions
Intervention1: Fixed Dose Combination (FDC) containing Rosuvastatin calcium with Ezetimibe: Rosuvastatin calcium 5/10/20 mg/day + Ezetimibe 10/10/10 mg/day
Control Intervention1: Monotherapy (Rosuvast
Sponsors
Biocon Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ?Male and female patients with hyper LDL cholesterolemia, aged 20-80 years (both years inclusive) ?Patients with LDL-C >=160 mg/dL and <250 mg/dL on fasting conditions ?Patients with hypercholesterolemia (with Non-HDL-C) who are above target goal according to NCEP-ATP III after 3 months of treatment with other conventional statin doses, e.g. simvastatin 10-40 mg. ?Patients who are willing to comply with all study requirements ?Females of childbearing potential should have a negative pregnancy test at the prestudy visit and agree to use contraception during the study ?Patients willing to give informed consent
Exclusion criteria
Exclusion criteria: ?Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits). ?Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment. ?Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study. ?Women of childbearing potential who are not using effective and medically acceptable methods of contraception. ?Patients who are meeting any of the contraindications of the study medication according to the approved Summary of Product Characteristics (SPC). ?Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism, liver disease (SGOT and/or SGPT levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout. ?Patients with diabetes will be included in the study if they are adequately controlled (HbA1c<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period). ?Patients who are positive for HIV test ?Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded ?Patients currently undertaking drugs like Cyclosporine, Niacin, Fenofibrate, Gemfibrozil, Lopinavir (or other protease inhibitors) Coumarin anticoagulants, clarithromycin, erythromycin, ketoconazole and itraconazole ?Patients with abnormal Creatine kinase (CK) level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage changes from baseline levels of LDL-C with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with ezetimibe 10 mg vs. monotherapy with rosuvastatin calcium 10 mg vs. ezetimibe 10 mg after 4 weeks of therapyTimepoint: 4 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in HDL-C, TC and fasting TG levels from the therapy initiation (baseline values) to the levels at the end of 4 weeks of the study.Timepoint: 4 Weeks treatment;The percentage of patients treated with FDC of rosuvastatin calcium (20/10/5 mg) with ezetimibe 10 mg vs. monotherapy of these drugs achieving LDL-C levels recommended by NCEP/ATP III, after 4 weeks of therapy.Timepoint: 4 Weeks treatment | — |
Countries
India
Contacts
Public ContactDr. Vanita Sabhahit
Outcome results
None listed