Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

Organon and Co4,748 enrolled

Overview

This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.

Study Type

OBSERVATIONAL

Enrollment

4,748

Conditions

Hypercholesterolemia

Interventions

Vytorin (R) (Ezetimibe + Simvastatin)DRUG

Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatient men or women, age 18 years and above * Patients with primary (heterozygous familial and non-familial) hypercholesterolemia Exclusion Criteria: * Known hypersensitivity to Ezetimibe and Simvastatin * Moderate to severe hepatic insufficiency * Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal * Pregnancy or lactation * Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

Outcomes

Primary Outcomes

Number of Participants Who Had an Adverse Event (AE).

The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia. All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.

Time frame: Throughout study up to Day 29 (Final Visit)

Data from ClinicalTrials.gov

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