EZETROL® Re-examination Study (MK0653-175)(COMPLETED)

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

Completed

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

Trial summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs. Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Hypercholesterolemia
How many people: 4,467 participants
Where: No sites listed yet
Study dates: Jan 2005to Jul 2010
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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants with Hypercholesterolemia treated with EZETROL®

Who may be able to join

Participants Who Receives EZETROL® In Usual Medical Practice

Who cannot join

None listed.

About this study

Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice

Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Medical subject headings: Hypercholesterolemia

What participants receive

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

Study groups in NCT01070953
Study group	Role	What they receive
EZETROL® 10 mg		Participants with Hypercholesterolemia treated with EZETROL®

What is being measured

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

Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Measured: Up to 14 days after treatment discontinuation
Mean Percent Change From Baseline to Treatment in Lipid Parameters
The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.
Measured: Baseline to 4 weeks
Overall Efficacy Evaluation of EZETROL®
Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.
Measured: Baseline to 4 weeks

Timeline

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

Jan 2005Jul 2010

First posted18 Feb 2010 (estimated)
Study startJan 2005
Primary completionJul 2010
Study completionJul 2010

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 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: Other
Time perspective: Prospective
Enrolment: 4,467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070953
Sponsor's protocol ID: 0653-175
Other IDs: 2010_009
Status last verified: Feb 2022
First submitted: 17 Feb 2010
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

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia

All 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: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice
ClinicalTrials.gov ID: NCT01070953
Acronym / sponsor ID: 0653-175
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Study type: Observational
Recruitment status: Completed
Enrolment: 4,467 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 4 Nov 2011

Clinical summary

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

Study design

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

Arm	Type	Receives
EZETROL® 10 mg	–	–Participants with Hypercholesterolemia treated with EZETROL®

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants with Hypercholesterolemia treated with EZETROL®

Key inclusion criteria (1 listed)

Participants Who Receives EZETROL® In Usual Medical Practice

Key exclusion criteria (0 listed)

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

Primary outcome

Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
Time frame: Up to 14 days after treatment discontinuation
Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Mean Percent Change From Baseline to Treatment in Lipid Parameters
Time frame: Baseline to 4 weeks
The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.
Overall Efficacy Evaluation of EZETROL®
Time frame: Baseline to 4 weeks
Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.

Results and safety

Results posted to the registry on 4 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EZETROL® 10 mg	4,467	3,536

Primary outcome: Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation

Time frame: Up to 14 days after treatment discontinuation. Number. Unit: participants

Measure	EZETROL® 10 mg n = 4467
Value	257

Primary outcome: Mean Percent Change From Baseline to Treatment in Lipid Parameters

Time frame: Baseline to 4 weeks. Mean (Standard Deviation). Unit: percentage of change

Measure	All Participants n = 3309
TC (n = 2439)	-21.23 (21.16)
HDL (n = 1928)	3.47 (19.81)
LDL (n = 1774)	-24.06 (33.49)
TG ( n = 2083)	-10.37 (45.05)

Population analysed: 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded

Primary outcome: Overall Efficacy Evaluation of EZETROL®

Time frame: Baseline to 4 weeks. Number. Unit: participants

Measure	EZETROL® 10 mg n = 3309
Improved	3029
Unchanged	241
Worsened	39
Total	3309

Population analysed: 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded

Adverse events

Time frame: Year 1 through Year 6.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EZETROL Year 1	0 of 67 (0%)	0 of 67 (0%)	Not reported
EZETROL Year 2	3 of 1,135 (0.3%)	5 of 1,135 (0.4%)	Not reported
EZETROL Year 3	18 of 1,039 (1.7%)	3 of 1,039 (0.3%)	Not reported
EZETROL Year 4	9 of 766 (1.2%)	0 of 766 (0%)	Not reported
EZETROL Year 5	4 of 154 (2.6%)	0 of 154 (0%)	Not reported
EZETROL Year 6	2 of 375 (0.5%)	29 of 375 (7.7%)	Not reported

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 Hypercholesterolemia

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of 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 1 inclusion and 0 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 4 Nov 2011). 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?

Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation (time frame: Up to 14 days after treatment discontinuation). The study lists 3 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 NCT01070953.

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.