Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)NCT01070966

Vytorin Reexamination Study (0653A-174)

An observational study of Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH), 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

This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy 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: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Type of treatment: Pill or oral medicine
How many people: 2,089 participants
Where: No sites listed yet
Study dates: Jul 2005to Apr 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 Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin

Who may be able to join

Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

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 VYTORIN in Usual Practice

Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Keywords: Atherosclerosis
Medical subject headings: Homozygous Familial Hypercholesterolemia, Atherosclerosis

What participants receive

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

Study groups in NCT01070966
Study group	Role	What they receive
VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)
VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)
VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)
VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

What is being measured

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

Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Measured: Up to 14 days after the 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, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.
Measured: Baseline and up to 5 years

Timeline

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

Jul 2005Apr 2010

First posted18 Feb 2010 (estimated)
Study startJul 2005
Primary completionApr 2010
Study completionApr 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 Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)Studies 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: 2,089 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070966
Sponsor's protocol ID: 0653A-174
Other IDs: 2010_010
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

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 VYTORIN in Usual Practice
ClinicalTrials.gov ID: NCT01070966
Acronym / sponsor ID: 0653A-174
Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Keywords: Atherosclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 2,089 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 10 May 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: 4

Arm	Type	Receives
VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)	–	–Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)
VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)	–	–Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)
VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)	–	–Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)
VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)	–	–Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin

Key inclusion criteria (1 listed)

Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

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

Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
Time frame: Up to 14 days after the treatment discontinuation
Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Mean Percent Change From Baseline to Treatment in Lipid Parameters
Time frame: Baseline and up to 5 years
The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.

Results and safety

Results posted to the registry on 10 May 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
VYTORIN® 10/10 mg/Day to 10/80 mg/Day	2,089	2,011

Primary outcome: Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation

Time frame: Up to 14 days after the treatment discontinuation. Number. Unit: Percentage of Participants

Measure	Participants Treated With VYTORIN n = 2011
Value	5.72

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

Time frame: Baseline and up to 5 years. Mean (Standard Deviation). Unit: percentage change

Measure	Participants Baseline Lipid Parameters n = 2011	Participants Treatment Lipid Parameters n = 2011	Participants Percent Change n = 2011
TC (n = 1965, 1993, 1956)	231.31 (46.33)	173.00 (40.78)	-23.90 (17.45)
HDL (n = 1805, 1782, 1705)	49.64 (13.42)	49.85 (13.17)	2.06 (15.27)
LDL (n = 1096, 1128, 1012)	151.32 (39.09)	104.34 (37.09)	-28.93 (23.52)
TG (n = 1843, 1824, 1766)	200.07 (128.76)	168.33 (102.82)	-7.37 (41.99)

Adverse events

Time frame: Year 1 through Year 6. There were no SAE's reported in Year three.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VYTORIN YEAR 1	0 of 9 (0%)	0 of 9 (0%)	Not reported
VYTORIN YEAR 2	4 of 933 (0.4%)	0 of 933 (0%)	Not reported
VYTORIN YEAR 4	6 of 531 (1.1%)	0 of 531 (0%)	Not reported
VYTORIN YEAR 5	0 of 380 (0%)	0 of 380 (0%)	Not reported
VYTORIN YEAR 6	5 of 158 (3.2%)	0 of 158 (0%)	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.

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 (HoFH), 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 10 May 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?

Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation (time frame: Up to 14 days after the treatment discontinuation). The study lists 2 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 NCT01070966.

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.