Primary HypercholesterolemiaPhase 4NCT00871351

Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

A Phase 4 study testing Ezetimibe, Atorvastatin and Rosuvastatin in people with Primary 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 efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Primary Hypercholesterolemia
What is being tested?: Ezetimibe, Atorvastatin and Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: No sites listed yet
Study dates: 1 Feb 2009to 1 May 2010
Phase: Phase 4
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

atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
outpatient men or women, age 20 years and older

Who cannot join

fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
homozygous familial hypercholesterolemia.
creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
glycosylated hemoglobin (HbA1c) >=8％ at start of washout or treatment period.
severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.
hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.

Show all 13Show fewer

pregnant or lactating
discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
cyclosporine treatment
hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
participation in a clinical study within 4 weeks of washout
cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.

About this study

Official title: Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia

Conditions: Primary Hypercholesterolemia
Being tested: Ezetimibe, Atorvastatin, Rosuvastatin

What participants receive

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

EzetimibeDrug
Also called SCH 058235
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
AtorvastatinDrug
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
AtorvastatinDrug
2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
RosuvastatinDrug
1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Study groups in NCT00871351
Study group	Role	What they receive
Ezetimibe + Atorvastatin	Experimental	Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg Receives: Drug: Ezetimibe; Drug: Atorvastatin
Atorvastatin	Active comparator	Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg Receives: Drug: Atorvastatin
Rosuvastatin	Active comparator	Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg Receives: Drug: Rosuvastatin

What is being measured

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

Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).
Measured: End of Week 4 to Week 16 or discontinuation

Secondary outcomes (4)

Percent Change in LDL-C
LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).
Measured: End of washout period to Week 16 or discontinuation
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).
Target values:
For participants with history of coronary artery disease: <100 mg/dL;
for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;
for participants with 1-2 CV risk factors: <140 mg/dL;
for participants with no CV risk factors: <160 mg/dL.
Measured: Week 16 or discontinuation
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.
Measured: End of Week 4 to Week 16 or discontinuation
Percent Change in Total Lipids and Hs-CRP
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).
Measured: End of washout to Week 16 or discontinuation

Timeline

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

1 Feb 20091 May 2010

First posted30 Mar 2009 (estimated)
Study start1 Feb 2009
Primary completion1 May 2010
Study completion1 May 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.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00871351
Sponsor's protocol ID: P06027
Status last verified: Feb 2022
First submitted: 26 Mar 2009
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.
PubMed 24653510

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
Not yet recruitingObservational study
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
Essential Hypertension, Primary Hypercholesterolemia
Not yet recruitingPhase 3
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemia or Mixed Hyperlipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia
ClinicalTrials.gov ID: NCT00871351
Acronym / sponsor ID: P06027
Conditions: Primary Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Feb 2009 (actual)
Primary completion: 1 May 2010 (actual)
Study completion: 1 May 2010 (actual)
First posted: 30 Mar 2009 (estimated)
Results: Posted 23 Aug 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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ezetimibe + Atorvastatin	Experimental	Drug: Ezetimibe, Drug: AtorvastatinParticipants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Atorvastatin	Active comparator	Drug: AtorvastatinParticipants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Rosuvastatin	Active comparator	Drug: RosuvastatinParticipants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
outpatient men or women, age 20 years and older

Key exclusion criteria (13 listed)

fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
homozygous familial hypercholesterolemia.
creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
glycosylated hemoglobin (HbA1c) >=8％ at start of washout or treatment period.
severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.

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 0582351 tablet of 10 mg daily for 12 weeks (Weeks 5-16)	Drug	Ezetimibe + Atorvastatin
Atorvastatin1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)	Drug	Ezetimibe + Atorvastatin
Atorvastatin2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)	Drug	Atorvastatin
Rosuvastatin1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)	Drug	Rosuvastatin

Primary outcome

Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
Time frame: End of Week 4 to Week 16 or discontinuation
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).

4 secondary outcomes

Percent Change in LDL-C
Time frame: End of washout period to Week 16 or discontinuation
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
Time frame: Week 16 or discontinuation
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: End of Week 4 to Week 16 or discontinuation
Percent Change in Total Lipids and Hs-CRP
Time frame: End of washout to Week 16 or discontinuation

Results and safety

Results posted to the registry on 23 Aug 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
Ezetimibe + Atorvastatin	47	43
Atorvastatin	46	45
Rosuvastatin	32	32

Primary outcome: Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values

Time frame: End of Week 4 to Week 16 or discontinuation. Mean (95% Confidence Interval). Unit: Percent change

Measure	Ezetimibe + Atorvastatin n = 47	Atorvastatin n = 46	Rosuvastatin n = 32
Value	-25.8 (-29.2 to -22.4)	-15.1 (-18.6 to -11.7)	0.8 (-3.3 to 4.9)

Ezetimibe + Atorvastatin vs Atorvastatin: Mean Difference (Net): -10.6 (95% CI -15.4 to -5.8), p <0.0001, Hochberg's method
Ezetimibe + Atorvastatin vs Rosuvastatin: Mean Difference (Net): -26.5 (95% CI -31.8 to -21.2), p <0.0001, Hochberg's method

Population analysed: Randomized participants

4 secondary outcomes are 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 + Atorvastatin	4 of 47 (8.5%)	13 of 47 (27.7%)	Not reported
Atorvastatin	1 of 46 (2.2%)	5 of 46 (10.9%)	Not reported
Rosuvastatin	0 of 32 (0%)	9 of 32 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24653510Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.
Individual participant dataSharing planned: No

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
Not yet recruitingObservational study
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
Essential Hypertension, Primary Hypercholesterolemia
Not yet recruitingPhase 3
QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Not yet recruitingPhase 3
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
Primary Hypercholesterolemia or Mixed Hyperlipidemia

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 4 study testing Ezetimibe, Atorvastatin and Rosuvastatin in people with Primary 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 13 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 23 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 23 Aug 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?

Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values (time frame: End of Week 4 to Week 16 or discontinuation). 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 NCT00871351, which also lists 1 linked publication.

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 23 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.