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

April 24, 2018 updated by: Hikma Pharmaceuticals LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were recruited from 24 cardiology, endocrinology and general practitioner outpatient clinics in Lebanon

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in mean low-density lipoproteins (LDL-C)
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)
Time Frame: 2 months
2 months
Proportion of patients who meet their target (LDL-C)
Time Frame: 2 months
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hikma Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPS-LBN-2014-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypercholesterolemia

Clinical Trials on Rosuvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe