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Effectiveness and Safety Study of RAZEL (Rosuvastatin) in Real-World.

A Prospective, Observational, Multicentric, Real World Study to Evaluate Safety and Effectiveness of RAZEL (Rosuvastatin) & its combination in Clinical Practice in Indian Patients - NA

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056757
Enrollment
5400
Registered
2023-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E782- Mixed hyperlipidemia

Interventions

Intervention1: RAZEL (Rosuvastatin) 5/10/20/40 mg: Rosuvastatin (5/10/20/40 mg) will be given to patients daily for 12 weeks in the prescribed trial dosages. Use water to administer the prescribed med

Sponsors

JBChemicals Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

India

Contacts

Public ContactDr Kapil Mehta

J.B.Chemicals & Pharmaceuticals Ltd.

kapil.mehta@jbpharma.com7874856742

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026