Effectiveness and Safety Study of RAZEL (Rosuvastatin) in Real-World.
Phase 4
- Conditions
- Health Condition 1: E782- Mixed hyperlipidemia
- Registration Number
- CTRI/2023/08/056757
- Lead Sponsor
- JBChemicals Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult (at least 18 years of age) patients of any gender who are already diagnosed with dyslipidemia and those with newly diagnosed/untreated dyslipidemia and are prescribed rosuvastatin or its combination for the treatment of dyslipidemia as a primary and secondary prevention of cardiovascular events in the Indian settings.
2. Patients who are willing to provide written informed consent to share information.
Exclusion Criteria
1. Pregnant women and subjects/LAR who are unable or refused to provide consent will be excluded from the study. Patients having incomplete data will be excluded from the study.
2. The study did not direct the treatment plans which were entirely at the discretion of the physicians.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment pattern of RAZEL (Rosuvastatin) & its combination – Prescribed for dyslipidemia patients as primary prevention or secondary prevention, Duration of Therapy, Concomitant disease (comorbidity), concomitant medications.Timepoint: Baseline, 3 months (12 weeks)
- Secondary Outcome Measures
Name Time Method Change in Total CholesterolTimepoint: Baseline, 3 months (12 weeks);Change in HDL-CholesterolTimepoint: Baseline, 3 months (12 weeks);change in LDL-CholesterolTimepoint: Baseline, 3 months (12 weeks);Change in TriglycerideTimepoint: Baseline, 3 months (12 weeks);change in VLDL-CholesterolTimepoint: Baseline, 3 months (12 weeks);Global Assessment for Efficacy & SafetyTimepoint: Baseline, 3 months (12 weeks)