NCT00129402

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 11, 2010

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

August 9, 2005

Results QC Date

January 14, 2010

Last Update Submit

February 4, 2022

Conditions

Hypercholesterolemia

Keywords

cholesteroldrugshypercholesterolemiaadolescentrandomized controlled trials

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline to 6 weeks

Secondary Outcomes (5)

  • Percent Change From Baseline in Total Cholesterol (TC)

    baseline to 6 weeks

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

    baseline to 6 weeks

  • Percent Change From Baseline in Triglycerides (TG)

    baseline to 6 weeks

  • Percent Change From Baseline in Apolipoprotein B (Apo B)

    baseline to 6 weeks

  • Percent Change From Baseline in HDL-C

    baseline to 6 weeks

Study Arms (2)

Pooled subjects who received ezetimibe with simvastatin

EXPERIMENTAL

Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg

Drug: ezetimibe with simvastatin

Pooled subjects who received simvastatin monotherapy

ACTIVE COMPARATOR

Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg

Drug: simvastatin

Interventions

ezetimibe with simvastatinDRUG

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

Pooled subjects who received ezetimibe with simvastatin
simvastatinDRUG

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

Pooled subjects who received simvastatin monotherapy

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18940534DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

EzetimibeSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 8, 2022

Results First Posted

February 11, 2010

Record last verified: 2022-02