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OpenTrials
Completed

NCT Number: NCT03516955

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

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.

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Key information

Conditions

Primary Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Superstat ® Tablets 10mg, 20mg

Other names: Superstat ®

Primary outcomes

  1. Percent change in mean low-density lipoproteins (LDL-C)

    Time frame: 2 months

Secondary outcomes

  1. Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)

    Time frame: 2 months

  2. Proportion of patients who meet their target (LDL-C)

    Time frame: 2 months

  3. Incidence rate of adverse events (AEs) in association with generic rosuvastatin

    Time frame: 2 months

    Rate of AEs which might include the worsening in baseline medical conditions, the occurrence of new conditions, or a significant change in vital signs or laboratory values.

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Registry information

Official study title

Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 7, 2018
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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