To assess the efficacy and tolerability of Rosuvastatin, in the Indian patients, with Dyslipidemia
Not Applicable
Recruiting
- Conditions
- Patients with Dyslipidemia
- Registration Number
- CTRI/2018/08/015417
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
The Purpose of this study is to assess the efficacy of Rosuvastatin, 1O mg) once daily, by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of < 100 mg/dl after 24 weeks of therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 4000
Inclusion Criteria
- 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
- 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 treatment baseline, 12 , 24 weeks
- Secondary Outcome Measures
Name Time Method 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-C 24 Weeks Assess the safety of rosuvastatin by analyzing the adverse events reported and evaluated by the treating physician 24 weeks
Trial Locations
- Locations (2)
Cardiac Care And Counselling Center
🇮🇳Pune, MAHARASHTRA, India
Dr. Gokhales Clinic
🇮🇳Mumbai, MAHARASHTRA, India
Cardiac Care And Counselling Center🇮🇳Pune, MAHARASHTRA, IndiaDr Sunil SathePrincipal investigator9822030125svscardcare@gmail.com