Health Condition 1: null- Patients with Dyslipidemia
Conditions
Interventions
Intervention1: Rosuvastatin: Participants will be administrated with Rosuvastatin 5/1O/20/40 mg tablet orally once daily for 24 weeks
Control Intervention1: NA: NA
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. LDL-C levels of > 130 mg/dland 2. TG levels of 3. Willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Hypersensitivity to rosuvastatin 3. Other concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3 fatty acids 4. LDL-C > 250 mg/dL,Triglyceride level >500 mg/dl 5. Participation in another investigational drug trial within 4 weeks of trial enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in the subjects with optimal values of LDL-C [ 100 mg/dl] at the end of the treatmentTimepoint: baseline, 12 , 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the safety of rosuvastatin by analyzing the adverse events reported and evaluated by the treating physicianTimepoint: 24 weeks;To compare the effect of 24 weeks therapy with 5 mg/1O mg/20 mg/40 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C and Non-HDL-CTimepoint: 24 Weeks | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited, Bangalore
Outcome results
None listed