Primary HypercholesterolemiaNCT00704535

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

An observational study of Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
What is being tested?: Ezetimibe
Type of treatment: Pill or oral medicine
How many people: 4,105 participants
Where: No sites listed yet
Study dates: Mar 2006to Apr 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Filipino subjects with hypercholesterolemia

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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

Conditions: Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
Being tested: Ezetimibe
Medical subject headings: Homozygous Familial Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EzetimibeDrug
Also called SCH 58235
1 tablet of 10 mg once daily

Study groups in NCT00704535
Study group	Role	What they receive
Subjects with hypercholesterolemia		Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin Receives: Drug: Ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 28 days after Visit 1

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Apr 2008

First posted25 Jun 2008 (estimated)
Study startMar 2006
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704535
Sponsor's protocol ID: P04748
Status last verified: Feb 2022
First submitted: 23 Jun 2008
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients
ClinicalTrials.gov ID: NCT00704535
Acronym / sponsor ID: P04748
Conditions: Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
Study type: Observational
Recruitment status: Completed
Enrolment: 4,105 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 25 Jun 2008 (estimated)
Results: Posted 14 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects with hypercholesterolemia	–	Drug: EzetimibeSubjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Filipino subjects with hypercholesterolemia

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EzetimibeAlso: SCH 582351 tablet of 10 mg once daily	Drug	Subjects with hypercholesterolemia

Primary outcome

Safety as Measured by Number of Subjects With at Least One Adverse Event
Time frame: 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
Safety as Measured by Number and Type of Adverse Events.
Time frame: 28 days after Visit 1
Evaluation 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 Investigator
Time frame: 28 days after Visit 1
To 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.
Time frame: 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.
Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event
Time frame: 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
Safety as Measured by Outcome of Adverse Events
Time frame: 28 days after Visit 1
To evaluate overall safety of ezetimibe as measured by outcome of adverse events
Tolerability as Measured by Subject Self-assessment
Time frame: 28 days after Visit 1
Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment

1 secondary outcome

To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)
Time frame: 28 days after Visit 1

Results and safety

Results posted to the registry on 14 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe as Prescribed by the Physician in Normal Practice	4,105	3,959

Primary outcome: Safety as Measured by Number of Subjects With at Least One Adverse Event

Time frame: 28 days after Visit 1. Number. Unit: subjects

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n = 4105
Value	45

Primary outcome: Safety as Measured by Number and Type of Adverse Events.

Time frame: 28 days after Visit 1. Number. Unit: adverse events

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n = 4105
gastrointestinal upset	2
abdominal pain	4
body weakness	1
constipation	3
crampy abdominal pain	1
diarrhea	6
dizziness	4
epigastric discomfort	1

Primary outcome: Safety as Measured by Severity of Adverse Events as Determined by the Investigator

Time frame: 28 days after Visit 1. Number. Unit: adverse events

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n = 4105
Mild adverse events	49
Moderate adverse events	4
Severe adverse events	1

Primary outcome: Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.

Time frame: 28 days after Visit 1. Number. Unit: adverse events

Measure	Ezetimibe as Prescribed by the Physician in Normal Practice n = 4105
Related to treatment	20
Not related to treatment	8
Relatedness not reported	26

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe as Prescribed by the Physician in Normal Practice	3 of 4,105 (0.1%)	0 of 4,105 (0%)	Not reported

Limitations and caveats (from the sponsor): Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as Measured by Number of Subjects With at Least One Adverse Event (time frame: 28 days after Visit 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00704535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.