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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516955
• Other study ID #: SPS-LBN-2014-05
• Status: Completed
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Hikma Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
Superstat ® Tablets 10mg, 20mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hikma Pharmaceuticals LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in mean low-density lipoproteins (LDL-C)		2 months
Secondary	Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)		2 months
Secondary	Proportion of patients who meet their target (LDL-C)		2 months
Secondary	Incidence rate of adverse events (AEs) in association with generic rosuvastatin	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