Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients

The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia

Study Overview

• Status: Completed
• Conditions: Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia
• Intervention / Treatment: Drug: Ezetimibe

• Study Type: Observational
• Enrollment (Actual): 4105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Filipino subjects with hypercholesterolemia

Description

Inclusion Criteria:

• Outpatient men or women, age 18 years and above.
• Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria:

• Known hypersensitivity to Ezetimibe.
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with hypercholesterolemia; Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin	Drug: Ezetimibe; 1 tablet of 10 mg once daily; Other Names: SCH 58235

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Measured by Number of Subjects With at Least One Adverse Event	Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event	28 days after Visit 1
Safety as Measured by Number and Type of Adverse Events.	Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.	28 days after Visit 1
Safety as Measured by Severity of Adverse Events as Determined by the Investigator	To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator	28 days after Visit 1
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.	To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.	28 days after Visit 1
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event	To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event	28 days after Visit 1
Safety as Measured by Outcome of Adverse Events	To evaluate overall safety of ezetimibe as measured by outcome of adverse events	28 days after Visit 1
Tolerability as Measured by Subject Self-assessment	Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment	28 days after Visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)	Change in mean total cholesterol values	28 days after Visit 1

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 23, 2008
• First Posted (Estimate): June 25, 2008

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypercholesterolemia; Hyperlipoproteinemia Type II; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe
• Other Study ID Numbers: P04748