Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting

NCT ID: NCT03516955

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 317 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

Brief Summary

This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.

Detailed Description

An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®).

Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study.

Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.

Conditions

Primary Hypercholesterolemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Rosuvastatin

Superstat ® Tablets 10mg, 20mg

Intervention Type: DRUG

Other Intervention Names

Superstat ®

Eligibility Criteria

Inclusion Criteria

• Males and females ≥ 18 years of age
• Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention
• Patients provided written informed consent

Exclusion Criteria

• Age <18 years
• Statin use in the past 3 months
• Any contraindication to HMG-CoA reductase inhibitors
• Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3)
• Conditions which may cause secondary dyslipidemia
• Any of the following abnormal laboratory tests:

TG level of > 400 mg/dL, Abnormal liver enzymes (AST or ALT) ≥ 3 ULN, Abnormal serum creatine kinase (CK) > 5 ULN

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SPS-LBN-2014-05

Identifier Type: -

Identifier Source: org_study_id