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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00704535
• Collaborator: (none)
• Enrollment: 4,105
• Duration (Months): 25

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia; Homozygous Familial Hypercholesterolemia	Drug: Ezetimibe

Study Design

• Study Type: Observational
• Actual Enrollment: 4105 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Safety as Measured by Number of Subjects With at Least One Adverse Event [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

2. Safety as Measured by Number and Type of Adverse Events. [28 days after Visit 1]

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

3. Safety as Measured by Severity of Adverse Events as Determined by the Investigator [28 days after Visit 1]

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

4. Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. [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.

5. Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event [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

6. Safety as Measured by Outcome of Adverse Events [28 days after Visit 1]

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

7. Tolerability as Measured by Subject Self-assessment [28 days after Visit 1]

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

Secondary Outcome Measures

1. To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) [28 days after Visit 1]

   Change in mean total cholesterol values

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00704535
• Other Study ID Numbers: P04748
• First Posted: Jun 25, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Ezetimibe

Study Results

Participant Flow

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Period Title: Overall Study
STARTED	4105
COMPLETED	3959
NOT COMPLETED	146

Baseline Characteristics

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Overall Participants	4105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.62 (11.60)
Sex/Gender, Customized (participants) [Number]
Female	2175 53%
Male	1930 47%

Outcome Measures

1. Primary Outcome

Title	Safety as Measured by Number of Subjects With at Least One Adverse Event
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Number [subjects]	45

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4083
Mean (Standard Deviation) [mg/dL]	-62.70 (47.05)

3. Primary Outcome

Title	Safety as Measured by Number and Type of Adverse Events.
Description	Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.
Time Frame	28 days after Visit 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
gastrointestinal upset	2
abdominal pain	4
body weakness	1
constipation	3
crampy abdominal pain	1
diarrhea	6
dizziness	4
epigastric discomfort	1
flatulence	2
headache	13
leg cramps/muscle pain	1
mild myalgia	2
myalgia	4
nausea	7
oily flatus	1
urticaria	1
vague abdominal discomfort	1

4. Primary Outcome

Title	Safety as Measured by Severity of Adverse Events as Determined by the Investigator
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Mild adverse events	49
Moderate adverse events	4
Severe adverse events	1

5. Primary Outcome

Title	Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Related to treatment	20
Not related to treatment	8
Relatedness not reported	26

6. Primary Outcome

Title	Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Treatment dosage unchanged	45
Treatment dosage reduced	6
Treatment temporarily discontinued	3

7. Primary Outcome

Title	Safety as Measured by Outcome of Adverse Events
Description	To evaluate overall safety of ezetimibe as measured by outcome of adverse events
Time Frame	28 days after Visit 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Adverse event cleared	49
Adverse event still present	2
Adverse event outcome not reported	3

8. Primary Outcome

Title	Tolerability as Measured by Subject Self-assessment
Description	Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment
Time Frame	28 days after Visit 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
Measure Participants	4105
Excellent	1325
Very good	1956
Good	713
Fair	54
Poor	3
Not reported	54

Adverse Events

Arm/Group Title	Ezetimibe as Prescribed by the Physician in Normal Practice
Arm/Group Description	Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
All Cause Mortality
	Ezetimibe as Prescribed by the Physician in Normal Practice
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ezetimibe as Prescribed by the Physician in Normal Practice
	Affected / at Risk (%)	# Events
Total	3/4105 (0.1%)
Infections and infestations
Sepsis	1/4105 (0%)	1
Nervous system disorders
Cerebrovascular accident	1/4105 (0%)	1
Haemorrhagic cerebral infarction	1/4105 (0%)	1
Other (Not Including Serious) Adverse Events
	Ezetimibe as Prescribed by the Physician in Normal Practice
	Affected / at Risk (%)	# Events
Total	0/4105 (0%)

Limitations/Caveats

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.