To assess the efficacy and tolerability of Rosuvastatin, in the Indian patients, with Dyslipidemia
Phase 4
- Conditions
- Health Condition 1: null- Patients with Dyslipidemia
- Registration Number
- CTRI/2018/08/015417
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. LDL-C levels of > 130 mg/dland < 250 mg/dl
2. TG levels of <500 mg/dl
3. Willing to sign the informed consent form
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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