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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00704535
Enrollment
4105
Registered
2008-06-25
Start date
2006-03-31
Completion date
2008-04-30
Last updated
2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homozygous Familial Hypercholesterolemia, Primary Hypercholesterolemia

Brief summary

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

Interventions

DRUGEzetimibe

1 tablet of 10 mg once daily

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tolerability as Measured by Subject Self-assessment28 days after Visit 1Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment
Safety as Measured by Number of Subjects With at Least One Adverse Event28 days after Visit 1Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event
Safety as Measured by Number and Type of Adverse Events.28 days after Visit 1Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.
Safety as Measured by Severity of Adverse Events as Determined by the Investigator28 days after Visit 1To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.28 days after Visit 1To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event28 days after Visit 1To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event
Safety as Measured by Outcome of Adverse Events28 days after Visit 1To evaluate overall safety of ezetimibe as measured by outcome of adverse events

Secondary

MeasureTime frameDescription
To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)28 days after Visit 1Change in mean total cholesterol values

Participant flow

Participants by arm

ArmCount
Ezetimibe as Prescribed by the Physician in Normal Practice
Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
4,105
Total4,105

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event2
Overall StudyCompleted status not on Case Report Form124
Overall StudyDeath2
Overall StudyLost to Follow-up8
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicEzetimibe as Prescribed by the Physician in Normal Practice
Age, Continuous54.62 years
STANDARD_DEVIATION 11.6
Sex/Gender, Customized
Female
2175 participants
Sex/Gender, Customized
Male
1930 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 4,105
serious
Total, serious adverse events
3 / 4,105

Outcome results

Primary

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.

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.Not related to treatment8 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.Relatedness not reported26 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.Related to treatment20 adverse events
Primary

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

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Dose Adjustment Upon Incidence of an Adverse EventTreatment dosage unchanged45 adverse event
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Dose Adjustment Upon Incidence of an Adverse EventTreatment dosage reduced6 adverse event
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Dose Adjustment Upon Incidence of an Adverse EventTreatment temporarily discontinued3 adverse event
Primary

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.

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.gastrointestinal upset2 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.abdominal pain4 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.body weakness1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.constipation3 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.crampy abdominal pain1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.diarrhea6 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.dizziness4 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.epigastric discomfort1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.flatulence2 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.headache13 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.leg cramps/muscle pain1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.mild myalgia2 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.myalgia4 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.nausea7 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.oily flatus1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.urticaria1 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number and Type of Adverse Events.vague abdominal discomfort1 adverse events
Primary

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

Time frame: 28 days after Visit 1

ArmMeasureValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Number of Subjects With at Least One Adverse Event45 subjects
Primary

Safety as Measured by Outcome of Adverse Events

To evaluate overall safety of ezetimibe as measured by outcome of adverse events

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Outcome of Adverse EventsAdverse event cleared49 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Outcome of Adverse EventsAdverse event still present2 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Outcome of Adverse EventsAdverse event outcome not reported3 adverse events
Primary

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

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Severity of Adverse Events as Determined by the InvestigatorMild adverse events49 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Severity of Adverse Events as Determined by the InvestigatorModerate adverse events4 adverse events
Ezetimibe as Prescribed by the Physician in Normal PracticeSafety as Measured by Severity of Adverse Events as Determined by the InvestigatorSevere adverse events1 adverse events
Primary

Tolerability as Measured by Subject Self-assessment

Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment

Time frame: 28 days after Visit 1

ArmMeasureGroupValue (NUMBER)
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentExcellent1325 subjects
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentVery good1956 subjects
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentGood713 subjects
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentFair54 subjects
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentPoor3 subjects
Ezetimibe as Prescribed by the Physician in Normal PracticeTolerability as Measured by Subject Self-assessmentNot reported54 subjects
Secondary

To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)

Change in mean total cholesterol values

Time frame: 28 days after Visit 1

Population: All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements

ArmMeasureValue (MEAN)Dispersion
Ezetimibe as Prescribed by the Physician in Normal PracticeTo Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)-62.70 mg/dLStandard Deviation 47.05

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026