Trial Outcomes & Findings for Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED) (NCT NCT00704535)

NCT ID: NCT00704535

Last Updated: 2022-02-09

Results Overview

Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event

• Recruitment status: COMPLETED
• Target enrollment: 4105 participants
• Primary outcome timeframe: 28 days after Visit 1
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	4105
Overall Study COMPLETED	3959
Overall Study NOT COMPLETED	146

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	2
Overall Study Death	2
Overall Study Lost to Follow-up	8
Overall Study Protocol Violation	10
Overall Study Completed status not on Case Report Form	124

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Age, Continuous	54.62 years STANDARD_DEVIATION 11.60 • n=5 Participants
Sex/Gender, Customized Female	2175 participants n=5 Participants
Sex/Gender, Customized Male	1930 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days after Visit 1

Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Number of Subjects With at Least One Adverse Event	45 subjects

PRIMARY outcome

Timeframe: 28 days after Visit 1

Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Number and Type of Adverse Events. epigastric discomfort	1 adverse events
Safety as Measured by Number and Type of Adverse Events. flatulence	2 adverse events
Safety as Measured by Number and Type of Adverse Events. headache	13 adverse events
Safety as Measured by Number and Type of Adverse Events. gastrointestinal upset	2 adverse events
Safety as Measured by Number and Type of Adverse Events. abdominal pain	4 adverse events
Safety as Measured by Number and Type of Adverse Events. body weakness	1 adverse events
Safety as Measured by Number and Type of Adverse Events. constipation	3 adverse events
Safety as Measured by Number and Type of Adverse Events. crampy abdominal pain	1 adverse events
Safety as Measured by Number and Type of Adverse Events. diarrhea	6 adverse events
Safety as Measured by Number and Type of Adverse Events. dizziness	4 adverse events
Safety as Measured by Number and Type of Adverse Events. leg cramps/muscle pain	1 adverse events
Safety as Measured by Number and Type of Adverse Events. mild myalgia	2 adverse events
Safety as Measured by Number and Type of Adverse Events. myalgia	4 adverse events
Safety as Measured by Number and Type of Adverse Events. nausea	7 adverse events
Safety as Measured by Number and Type of Adverse Events. oily flatus	1 adverse events
Safety as Measured by Number and Type of Adverse Events. urticaria	1 adverse events
Safety as Measured by Number and Type of Adverse Events. vague abdominal discomfort	1 adverse events

PRIMARY outcome

Timeframe: 28 days after Visit 1

To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Severity of Adverse Events as Determined by the Investigator Mild adverse events	49 adverse events
Safety as Measured by Severity of Adverse Events as Determined by the Investigator Moderate adverse events	4 adverse events
Safety as Measured by Severity of Adverse Events as Determined by the Investigator Severe adverse events	1 adverse events

PRIMARY outcome

Timeframe: 28 days after Visit 1

To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. Related to treatment	20 adverse events
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. Not related to treatment	8 adverse events
Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. Relatedness not reported	26 adverse events

PRIMARY outcome

Timeframe: 28 days after Visit 1

To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event Treatment dosage unchanged	45 adverse event
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event Treatment dosage reduced	6 adverse event
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event Treatment temporarily discontinued	3 adverse event

PRIMARY outcome

Timeframe: 28 days after Visit 1

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

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Safety as Measured by Outcome of Adverse Events Adverse event cleared	49 adverse events
Safety as Measured by Outcome of Adverse Events Adverse event still present	2 adverse events
Safety as Measured by Outcome of Adverse Events Adverse event outcome not reported	3 adverse events

PRIMARY outcome

Timeframe: 28 days after Visit 1

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

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Tolerability as Measured by Subject Self-assessment Not reported	54 subjects
Tolerability as Measured by Subject Self-assessment Excellent	1325 subjects
Tolerability as Measured by Subject Self-assessment Very good	1956 subjects
Tolerability as Measured by Subject Self-assessment Good	713 subjects
Tolerability as Measured by Subject Self-assessment Fair	54 subjects
Tolerability as Measured by Subject Self-assessment Poor	3 subjects

SECONDARY outcome

Timeframe: 28 days after Visit 1

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

Change in mean total cholesterol values

Outcome measures

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4083 Participants Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)	-62.70 mg/dL Standard Deviation 47.05

Adverse Events

Ezetimibe as Prescribed by the Physician in Normal Practice

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n=4105 participants at risk Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Infections and infestations Sepsis	0.02% 1/4105 • Number of events 1
Nervous system disorders Cerebrovascular accident	0.02% 1/4105 • Number of events 1
Nervous system disorders Haemorrhagic cerebral infarction	0.02% 1/4105 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President,Global Clinical Development

Merck Sharp & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The prescribing physicians and investigators of this trial will not publish the results of any part of the study without previous written authorization from the sponsor.
• Publication restrictions are in place

Restriction type: OTHER