CompletedNCT00129402Updated Feb 8, 2022Results posted

Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

A Phase 3 interventional study of ezetimibe with simvastatin and simvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 248
Allocation: Randomized
Ages: 10 Years to 17 Years
Sex: All

Study summary

This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.

Read the detailed description

This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups.

In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1.

In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.

Conditions studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,238

Keywords

cholesterol
drugs
hypercholesterolemia
adolescent
randomized controlled trials

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 248 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 10 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
Subjects must have high cholesterol (low density lipoprotein cholesterol [LDL-C] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.

Exclusion criteria

Exclusion Criteria:

Subjects diagnosed with delayed puberty.
Subjects who are sensitive to simvastatin and/or ezetimibe.
Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 248 participants (actual)

Study arms

Experimental
Pooled subjects who received ezetimibe with simvastatin
Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
Drug: ezetimibe with simvastatin
Active comparator
Pooled subjects who received simvastatin monotherapy
Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
Drug: simvastatin

Interventions

Drugezetimibe with simvastatin
Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks
Drugsimvastatin
Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks

What researchers measure

Primary outcomes

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy
Time frame: baseline to 6 weeks

Secondary outcomes

Percent Change From Baseline in Total Cholesterol (TC)
Time frame: baseline to 6 weeks
Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)
Time frame: baseline to 6 weeks
Percent Change From Baseline in Triglycerides (TG)
Time frame: baseline to 6 weeks
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time frame: baseline to 6 weeks
Percent Change From Baseline in HDL-C
Time frame: baseline to 6 weeks

Results

Posted Feb 11, 2010

Participant flow

Start Period1 to End Period1 (Week 1-6)

Participant flow — Start Period1 to End Period1 (Week 1-6)
Milestone	Ezetimibe/Simvastatin 10/10	Ezetimibe/Simvastatin 10/20	Ezetimibe/Simvastatin 10/40	Ezetimibe Matching Placebo/ Simvastatin 10	Ezetimibe Matching Placebo/ Simvastatin 20	Ezetimibe Matching Placebo/ Simvastatin 40
Started	43	40	43	40	40	42
Completed	43	39	41	39	39	40
Not completed	0	1	2	1	1	2
Withdrew: Adverse event	0	1	1	0	0	1
Withdrew: Lost to follow-up	0	0	0	0	0	1
Withdrew: Protocol violation	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	0	1	0	1	0

Start Period2 to End Period2 (Week 7-33)

Participant flow — Start Period2 to End Period2 (Week 7-33)
Milestone	Ezetimibe/Simvastatin 10/40	Ezetimibe Matching Placebo/ Simvastatin 40
Started	122	118
Completed	114	113
Not completed	8	5
Withdrew: Adverse event	2	0
Withdrew: Laboratory adverse event	3	1
Withdrew: Lost to follow-up	1	0
Withdrew: Withdrawal by subject	1	3
Withdrew: Protocol violation	1	1

Start Period3 to End Period3(Week 34-53)

Participant flow — Start Period3 to End Period3(Week 34-53)
Milestone	Ezetimibe/Simvastatin 10/10	Ezetimibe/Simvastatin 10/20	Ezetimibe/Simvastatin 10/40	Ezetimibe Matching Placebo/ Simvastatin 10	Ezetimibe Matching Placebo/ Simvastatin 20	Ezetimibe Matching Placebo/ Simvastatin 40	Long-term Experience Ezetimbe/Simvastatin
Started	0	0	0	0	0	0	228
Completed	0	0	0	0	0	0	222
Not completed	0	0	0	0	0	0	6
Withdrew: Lost to follow-up	0	0	0	0	0	0	1
Withdrew: Withdrawal by subject	0	0	0	0	0	0	3
Withdrew: Subject moved	0	0	0	0	0	0	1
Withdrew: Protocol violation	0	0	0	0	0	0	1

Outcome measures

PrimaryPercent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy

Time frame:: baseline to 6 weeks
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	-49.45 ± 1.19	-34.43 ± 1.22

Statistical analysis

Pooled Subjects Who Received Ezetimibe With Simvastatin vs Pooled Subjects Who Received Simvastatin Monotherapy · ANOVA · p = <0.01

SecondaryPercent Change From Baseline in Total Cholesterol (TC)

Time frame:: baseline to 6 weeks
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Total Cholesterol (TC)
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in Total Cholesterol (TC)	-38.23 ± .96	-26.28 ± .99

Statistical analysis

Pooled Subjects Who Received Simvastatin Monotherapy · ANOVA · p = <0.01

SecondaryPercent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)

Time frame:: baseline to 6 weeks
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)	-46.84 ± 1.13	-32.68 ± 1.16

Statistical analysis

Pooled Subjects Who Received Ezetimibe With Simvastatin vs Pooled Subjects Who Received Simvastatin Monotherapy · ANOVA · p = <0.01

SecondaryPercent Change From Baseline in Triglycerides (TG)

Time frame:: baseline to 6 weeks
Reported as:: Median · percent change

Percent Change From Baseline in Triglycerides (TG)
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in Triglycerides (TG)	-16.56 ± 30.26	-12.28 ± 31.49

Statistical analysis

Pooled Subjects Who Received Ezetimibe With Simvastatin vs Pooled Subjects Who Received Simvastatin Monotherapy · non-parametric model · p = .48

SecondaryPercent Change From Baseline in Apolipoprotein B (Apo B)

Time frame:: baseline to 6 weeks
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Apolipoprotein B (Apo B)
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in Apolipoprotein B (Apo B)	-38.92 ± 1.1	-26.69 ± 1.11

Statistical analysis

Pooled Subjects Who Received Ezetimibe With Simvastatin vs Pooled Subjects Who Received Simvastatin Monotherapy · ANOVA · p = <0.01

SecondaryPercent Change From Baseline in HDL-C

Time frame:: baseline to 6 weeks
Reported as:: Least squares mean · percent change

Percent Change From Baseline in HDL-C
percent change	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy
Percent Change From Baseline in HDL-C	6.58 ± 1.16	6.47 ± 1.19

Statistical analysis

Pooled Subjects Who Received Ezetimibe With Simvastatin vs Pooled Subjects Who Received Simvastatin Monotherapy · ANOVA · p = .95

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Ezetimibe With Simvastatin	—	4/126 (3.2%)	58/126 (46%)
Simvastatin Monotherapy	—	1/122 (0.8%)	59/122 (48.4%)
Long-term Coadministration of Ezetimibe With Simvastatin	—	3/227 (1.3%)	42/227 (18.5%)

Most frequent serious events

Most frequent serious events
Event	Ezetimibe With Simvastatin	Simvastatin Monotherapy	Long-term Coadministration of Ezetimibe With Simvastatin
Accidental overdoseInjury, poisoning and procedural complications	0/126	1/122	0/227
PyrexiaGeneral disorders	1/126	0/122	0/227
Arthritis bacterialInfections and infestations	1/126	0/122	0/227
TonsillitisInfections and infestations	1/126	0/122	0/227
TendonitisMusculoskeletal and connective tissue disorders	1/126	0/122	0/227
EncephalopathyNervous system disorders	1/126	0/122	0/227
Pilonidal cystInfections and infestations	0/126	0/122	1/227
Subcutaneous abscessInfections and infestations	0/126	0/122	1/227
OverdoseInjury, poisoning and procedural complications	0/126	0/122	1/227

Most frequent other events

Most frequent other events
Event	Ezetimibe With Simvastatin	Simvastatin Monotherapy	Long-term Coadministration of Ezetimibe With Simvastatin
NasopharyngitisInfections and infestations	27/126	27/122	16/227
HeadacheNervous system disorders	16/126	16/122	6/227
InfluenzaInfections and infestations	8/126	12/122	12/227
AcneSkin and subcutaneous tissue disorders	4/126	9/122	3/227
DiarrhoeaGastrointestinal disorders	9/126	3/122	2/227
CoughRespiratory, thoracic and mediastinal disorders	4/126	8/122	5/227
NauseaGastrointestinal disorders	8/126	4/122	2/227
MyalgiaMusculoskeletal and connective tissue disorders	7/126	1/122	0/227

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy	Total
Mean	14.0 ± 1.9	14.3 ± 1.8	14.2 ± 1.9

Sex: Female, Male
Sex: Female, Male(Participants)	Pooled Subjects Who Received Ezetimibe With Simvastatin	Pooled Subjects Who Received Simvastatin Monotherapy	Total
Female	53	53	106
Male	73	69	142

Study locations

No study locations are listed for this record.

References and documents

Publications

van der Graaf A, Cuffie-Jackson C, Vissers MN, Trip MD, Gagne C, Shi G, Veltri E, Avis HJ, Kastelein JJ. Efficacy and safety of coadministration of ezetimibe and simvastatin in adolescents with heterozygous familial hypercholesterolemia. J Am Coll Cardiol. 2008 Oct 21;52(17):1421-9. doi: 10.1016/j.jacc.2008.09.002. PubMed 18940534 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00129402
Lead sponsor: Organon and Co
Collaborators: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Aug 11, 2005
Start date: Aug 2005
Primary completion: Jun 2007
Completion: Jun 2007
Results posted: Feb 11, 2010
Last update: Feb 8, 2022

View the source record on ClinicalTrials.gov ↗

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Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

Study summary

Conditions studied

Browse trials for

Keywords

In context

Hypercholesterolemia

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria