HypercholesterolemiaPhase 3NCT00654095
Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
A Phase 3 study testing Ezetimibe and atorvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe and atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2007to 1 Jun 2009
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with hypercholesterolemia who satisfy the following criteria:
- Participants who have used any of the following 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose low density lipoprotein (LDL)-cholesterol level during the treatment had not reached lipid management target
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patient
Who cannot join
- Participants for whom any of the following is applicable:
- Participants whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
- Participants with homozygous familial hypercholesterolemia
- Participants with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
- Participants with serious hepatic disorder, or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
- Participants with a history of hypersensitivity to any ingredient of ezetimibe tablets or atorvastatin tablets
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- Pregnant, nursing women, women who may be pregnant, or participants wishing to be pregnant during the study.
- Participants who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the participant had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
- Participants who are using cyclosporine from after the start of the observation period
- Participants with a history of ezetimibe use
- Participants with hyperlipidemia associated with the following diseases:
- Hypothyroidism
- Obstructive gall bladder or biliary disease
- Chronic renal failure
- Pancreatitis
- Participants with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
- Participants who have received an investigational drug within 4 weeks of the start of the observation period
- Other participants deemed not appropriate for study entry by the investigator
About this study
Official title: Open-label, Long-term Study of Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe, atorvastatin
- Medical subject headings
- 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
Ezetimibe 10 mg once daily
atorvastatinDrug
atorvastatin 20 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe + Atorvastatin | Experimental | Ezetimibe 10 mg + Atorvastatin 20 mg Receives: Drug: Ezetimibe; Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Adverse Reactions
An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.
That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.
Any adverse event that was considered treatment-related was considered an adverse reaction.
Measured: Throughout 1 year of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study start1 Dec 2007
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654095
- Sponsor's protocol ID
- P05456
- Status last verified
- Feb 2022
- First submitted
- 1 Apr 2008
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Long-term Study of Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors
- ClinicalTrials.gov ID
- NCT00654095
- Acronym / sponsor ID
- P05456
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Posted 5 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe + Atorvastatin | Experimental | Drug: Ezetimibe, Drug: atorvastatinEzetimibe 10 mg + Atorvastatin 20 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with hypercholesterolemia who satisfy the following criteria:
Key exclusion criteria (18 listed)
- Participants for whom any of the following is applicable:
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 58235Ezetimibe 10 mg once daily | Drug | Ezetimibe + Atorvastatin |
| atorvastatinatorvastatin 20 mg once daily | Drug | Ezetimibe + Atorvastatin |
Primary outcome
Number of Participants With Adverse Events and Adverse Reactions
Time frame: Throughout 1 year of study
An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified. That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered. Any adverse event that was considered treatment-related was considered an adverse reaction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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?
A Phase 3 study testing Ezetimibe and atorvastatin in people with 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 5 inclusion and 18 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 21 May 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2010). 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?
Number of Participants With Adverse Events and Adverse Reactions (time frame: Throughout 1 year of study). 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 21 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.