CompletedNCT00871351Updated May 23, 2024Results posted

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

A Phase 4 interventional study of Ezetimibe and Atorvastatin in Primary Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 125
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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 increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Conditions studied

Primary Hypercholesterolemia

In context

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

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Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 125 participants (actual)

Study arms

Experimental
Ezetimibe + Atorvastatin
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
Drug: Ezetimibe · Drug: Atorvastatin
Active comparator
Atorvastatin
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Drug: Atorvastatin
Active comparator
Rosuvastatin
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Drug: Rosuvastatin

Interventions

DrugEzetimibe
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
Also known as: SCH 058235
DrugAtorvastatin
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
DrugAtorvastatin
2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
DrugRosuvastatin
1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

What researchers measure

Primary outcomes

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).
Time frame: End of Week 4 to Week 16 or discontinuation

Secondary outcomes

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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: End of washout to Week 16 or discontinuation

Results

Posted Aug 23, 2011

Participant flow

Participant flow — Overall Study
Milestone	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Started	47	46	32
Completed	43	45	32
Not completed	4	1	0
Withdrew: Withdrawal by subject	1	0	0
Withdrew: Adverse event	3	1	0

Outcome measures

PrimaryPercent 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).

Time frame:: End of Week 4 to Week 16 or discontinuation
Reported as:: Mean · Percent change

Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
Percent change	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values	-25.8 (-29.2 to -22.4)	-15.1 (-18.6 to -11.7)	0.8 (-3.3 to 4.9)

Statistical analysis

Ezetimibe + Atorvastatin vs Atorvastatin · Hochberg's method · p = <0.0001 · Mean difference (net): -10.6 · 95% CI -15.4 to -5.8
Ezetimibe + Atorvastatin vs Rosuvastatin · Hochberg's method · p = <0.0001 · Mean difference (net): -26.5 · 95% CI -31.8 to -21.2

SecondaryPercent 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).

Time frame:: End of washout period to Week 16 or discontinuation
Reported as:: Mean · Percent change

Percent Change in LDL-C
Percent change	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Percent Change in LDL-C	-49.6 (-52.9 to -46.4)	-41.1 (-44.4 to -37.9)	-30.5 (-34.4 to -26.6)

Statistical analysis

Ezetimibe + Atorvastatin vs Atorvastatin · Hochberg's method · p = 0.0003
Ezetimibe + Atorvastatin vs Rosuvastatin · Hochberg's method · p = <0.0001

SecondaryNumber 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.

Time frame:: Week 16 or discontinuation
Reported as:: Number · Participants

Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
Participants	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values	37	19	1

SecondaryPercent 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.

Time frame:: End of Week 4 to Week 16 or discontinuation
Reported as:: Mean · Percent change

Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Percent change	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Total Cholesterol	-18.0 (-20.7 to -15.2)	-10.3 (-13.1 to -7.4)	1.9 (-1.7 to 5.5)
Triglycerides	-0.8 (-14.4 to 12.8)	0.2 (-10.9 to 11.4)	14.7 (2.3 to 27.0)
High-Density Lipoprotein Cholesterol (HDL-C)	4.5 (0.9 to 8.2)	0.5 (-2.6 to 3.5)	2.5 (-1.4 to 6.4)
Non-HDL-C	-25.0 (-28.5 to -21.5)	-13.7 (-17.0 to -10.3)	2.0 (-2.6 to 6.5)
High Sensitivity C-Reactive Protein (Hs-CRP)	49.0 (-43.2 to 141.3)	9.9 (-24.1 to 43.9)	25.7 (-4.8 to 56.1)

SecondaryPercent 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).

Time frame:: End of washout to Week 16 or discontinuation
Reported as:: Mean · Percent change

Percent Change in Total Lipids and Hs-CRP
Percent change	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
Total Cholesterol	-39.9 (-42.1 to -37.7)	-32.8 (-35.8 to -29.7)	-24.4 (-27.9 to -21.0)
Triglycerides	-25.3 (-36.0 to -14.6)	-18.8 (-29.8 to -7.8)	-12.0 (-21.3 to -2.7)
High-Density Lipoprotein Cholesterol (HDL-C)	10.3 (6.1 to 14.5)	7.4 (3.7 to 11.0)	9.9 (3.6 to 16.2)
Non-HDL-C	-50.1 (-52.7 to -47.6)	-41.4 (-44.8 to -37.9)	-31.3 (-35.4 to -27.1)
High Sensitivity C-reactive Protein (Hs-CRP)	73.0 (-84.4 to 230.4)	-2.9 (-36.3 to 30.4)	-13.6 (-39.7 to 12.6)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ezetimibe + Atorvastatin	—	4/47 (8.5%)	13/47 (27.7%)
Atorvastatin	—	1/46 (2.2%)	5/46 (10.9%)
Rosuvastatin	—	0/32 (0%)	9/32 (28.1%)

Most frequent serious events

Most frequent serious events
Event	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
PneumoniaInfections and infestations	0/47	1/46	0/32
Chest discomfortGeneral disorders	1/47	0/46	0/32
Heat illnessInjury, poisoning and procedural complications	1/47	0/46	0/32
Carcinoid tumour of the gastrointestinal tractNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/47	0/46	0/32
Rectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/47	0/46	0/32

Most frequent other events

Most frequent other events
Event	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin
NasopharyngitisInfections and infestations	7/47	5/46	3/32
HeadacheNervous system disorders	1/47	0/46	3/32
HypertensionVascular disorders	2/47	0/46	3/32
Blood creatine phosphokinase increasedInvestigations	3/47	0/46	0/32
DizzinessNervous system disorders	0/47	0/46	2/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin	Total
Mean	62.7 ± 11.4	59.3 ± 11.8	61.1 ± 12.0	61.0 ± 11.7

Sex: Female, Male
Sex: Female, Male(Participants)	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin	Total
Female	25	22	17	64
Male	22	24	15	61

Region of Enrollment
Region of Enrollment(participants)	Ezetimibe + Atorvastatin	Atorvastatin	Rosuvastatin	Total
Japan	47	46	32	125

Study locations

No study locations are listed for this record.

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00871351
Lead sponsor: Organon and Co
Responsible party: Sponsor
First posted: Mar 30, 2009
Start date: Feb 1, 2009
Primary completion: May 1, 2010
Completion: May 1, 2010
Results posted: Aug 23, 2011
Last update: May 23, 2024

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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