HypercholesterolemiaNCT00705211
A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)
An observational study of Hypercholesterolemia and Familial Hypercholesterolemia, run by Organon and Co.
Trial summary
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia, Familial Hypercholesterolemia, Homozygous Sitosterolemia
- What is being tested?
- Ezetimibe and Ezetimibe + other lipid-lowering medication(s)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,794 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population will be selected from 200 institutions in Japan.
Who may be able to join
- Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.
- Zetia monotherapy patients must be treated with Zetia alone.
- Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.
Who cannot join
- Patients with a history of hypersensitivity to any ingredient in Zetia
- Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
About this study
Official title: Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Read the detailed description
The population will be selected from 200 institutions in Japan.
- Being tested
- Ezetimibe, Ezetimibe + other lipid-lowering medication(s)
- Medical subject headings
- Hypercholesterolemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called Zetia
Ezetimibe, 10-mg tablets,
Ezetimibe + other lipid-lowering medication(s)Drug
Also called Zetia + other lipid-lowering medication(s)
Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician
| Study group | Role | What they receive |
|---|---|---|
| Zetia monotherapy | Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia Receives: Drug: Ezetimibe | |
| Zetia combination therapy | Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia Receives: Drug: Ezetimibe + other lipid-lowering medication(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A primary endpoint is the incidence of adverse events.
Measured: Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
A primary endpoint is change in LDL-C
Measured: LDL-C at start of 52 weeks will be compared to LDL-C at the end of the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705211
- Sponsor's protocol ID
- P05245
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
- ClinicalTrials.gov ID
- NCT00705211
- Acronym / sponsor ID
- P05245
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,794 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Detailed description
The population will be selected from 200 institutions in Japan.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zetia monotherapy | – | Drug: EzetimibePatients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia |
| Zetia combination therapy | – | Drug: Ezetimibe + other lipid-lowering medication(s)Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will be selected from 200 institutions in Japan.
Key inclusion criteria (3 listed)
- Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.
- Zetia monotherapy patients must be treated with Zetia alone.
- Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to any ingredient in Zetia
- Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
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: ZetiaEzetimibe, 10-mg tablets, | Drug | Zetia monotherapy |
| Ezetimibe + other lipid-lowering medication(s)Also: Zetia + other lipid-lowering medication(s)Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician | Drug | Zetia combination therapy |
Primary outcome
A primary endpoint is the incidence of adverse events.
Time frame: Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
A primary endpoint is change in LDL-C
Time frame: LDL-C at start of 52 weeks will be compared to LDL-C at the end of the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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 Hypercholesterolemia and 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 3 inclusion and 2 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 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A primary endpoint is the incidence of adverse events. (time frame: Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy 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?
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 16 Feb 2022.