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Primary Hypercholesterolemia

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

Sponsored by Hikma Pharmaceuticals LLC

About this trial

Last updated 7 years ago

Study ID

SPS-LBN-2014-05

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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