Primary HypercholesterolemiaPhase 3NCT00867165
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
A Phase 3 study testing ezetimibe in people with Primary Hypercholesterolemia, run by Organon and Co.
Trial summary
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2009to 13 Apr 2012
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
- Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Who cannot join
- Each subject must not:
- Have known hypersensitivity or any contraindication to ezetimibe.
- Have use of any investigational drugs within 30 days of study entry.
- Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
- Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
- Have known congenital cardiac disorder.
- Have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH).
- Be known to be human immunodeficiency virus (HIV) positive.
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- ezetimibe, Placebo
- Keywords
- heterozygous familial hypercholesterolemia, nonfamilial 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, MK-0653, Zetia
oral tablets: ezetimibe 10 mg once daily for 12 weeks
PlaceboDrug
oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Experimental | Ezetimibe 10-mg tablet once daily for 12 weeks Receives: Drug: ezetimibe |
| Placebo | Placebo comparator | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).
Measured: Baseline and Week 12
Secondary outcomes (48)
Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Serum Apo B measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Non-HDL-C at Week 12
Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Measured: Baseline and Week 12
Percentage Change From Baseline in Triglycerides (TG) at Week 12
Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.
Measured: Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 2
Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).
Measured: Baseline and Week 2
Percent Change From Baseline in LDL-C at Week 4
Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).
Measured: Baseline and Week 4
Percent Change From Baseline in LDL-C at Week 8
Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).
Measured: Baseline and Week 8
Percentage Change From Baseline in TC at Week 2
Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in TC at Week 4
Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in TC at Week 8
Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline HDL-C at Week 2
Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline HDL-C at Week 4
Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline HDL-C at Week 8
Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Non-HDL-C at Week 2
Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Measured: Baseline and Week 2
Percentage Change From Baseline in Non-HDL-C at Week 4
Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Measured: Baseline and Week 4
Percentage Change From Baseline in Non-HDL-C at Week 8
Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC - HDL-C.
Measured: Baseline and Week 8
Percentage Change From Baseline in TG at Week 2
Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in TG at Week 4
Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in TG at Week 8
Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12
Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in TC:HDL-C Ratio at Week 2
Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in TC:HDL-C Ratio at Week 4
Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in TC:HDL-C Ratio at Week 8
Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in TC:HDL-C Ratio at Week 12
Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2
Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4
Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8
Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12
Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12
Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration
Measured: Baseline and Week 12
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4
Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12
Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percent Change From Baseline in Sitosterol at Week 2
Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in Sitosterol at Week 4
Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in Sitosterol at Week 8
Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Sitosterol at Week 12
Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Campesterol at Week 2
Plasma campesterol measured at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in Campesterol at Week 4
Plasma campesterol measured at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in Campesterol at Week 8
Plasma campesterol measured at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Campesterol at Week 12
Plasma campesterol measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Cholestanol at Week 2
Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in Cholestanol at Week 4
Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in Cholestanol at Week 8
Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Cholestanol at Week 12
Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Percentage Change From Baseline in Lathosterol at Week 2
Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.
Measured: Baseline and Week 2
Percentage Change From Baseline in Lathosterol at Week 4
Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.
Measured: Baseline and Week 4
Percentage Change From Baseline in Lathosterol at Week 8
Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.
Measured: Baseline and Week 8
Percentage Change From Baseline in Lathosterol at Week 12
Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study start21 May 2009
- Primary completion13 Apr 2012
- Study completion13 Apr 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867165
- Sponsor's protocol ID
- P05522
- Other IDs
- 2008-006271-70, MK-0653-170, 2008
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2009
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kusters DM, Caceres M, Coll M, Cuffie C, Gagne C, Jacobson MS, Kwiterovich PO, Lee R, Lowe RS, Massaad R, McCrindle BW, Musliner TA, Triscari J, Kastelein JJ. Efficacy and safety of ezetimibe monotherapy in children with heterozygous familial or nonfamilial hypercholesterolemia. J Pediatr. 2015 Jun;166(6):1377-84.e1-3. doi: 10.1016/j.jpeds.2015.02.043. Epub 2015 Apr 1.
PubMed 25841542
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
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) (Phase 3, Protocol No. P05522)
- ClinicalTrials.gov ID
- NCT00867165
- Acronym / sponsor ID
- P05522
- Conditions
- Primary Hypercholesterolemia
- Keywords
- heterozygous familial hypercholesterolemia, nonfamilial hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 May 2009 (actual)
- Primary completion
- 13 Apr 2012 (actual)
- Study completion
- 13 Apr 2012 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 30 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Experimental | Drug: ezetimibeEzetimibe 10-mg tablet once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Each subject may be of either sex and of any race/ethnicity, and must be >=6 and <=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of >159mg/dL
- Each subject's parent/guardian must be willing to give written informed consent on his/her behalf.
Key exclusion criteria (8 listed)
- Have known hypersensitivity or any contraindication to ezetimibe.
- Have use of any investigational drugs within 30 days of study entry.
- Be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial.
- Be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
- Have known congenital cardiac disorder.
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 58235, MK-0653, Zetiaoral tablets: ezetimibe 10 mg once daily for 12 weeks | Drug | Ezetimibe |
| Placebooral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period | Drug | Placebo |
Primary outcome
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).
48 secondary outcomes
Percentage Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Triglycerides (TG) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 2
Time frame: Baseline and Week 2
Percent Change From Baseline in LDL-C at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in LDL-C at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in TC at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in TC at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in TC at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline HDL-C at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline HDL-C at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline HDL-C at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in Non-HDL-C at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in Non-HDL-C at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in Non-HDL-C at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in TG at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in TG at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in TG at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in TC:HDL-C Ratio at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in TC:HDL-C Ratio at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in TC:HDL-C Ratio at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in TC:HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Sitosterol at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in Sitosterol at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in Sitosterol at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in Sitosterol at Week 12
Time frame: Baseline and Week 12
Percentage Change From Baseline in Campesterol at Week 2
Time frame: Baseline and Week 2
Percentage Change From Baseline in Campesterol at Week 4
Time frame: Baseline and Week 4
Percentage Change From Baseline in Campesterol at Week 8
Time frame: Baseline and Week 8
Percentage Change From Baseline in Campesterol at Week 12
Time frame: Baseline and Week 12
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.
- Results publication: PubMed 25841542Kusters DM, Caceres M, Coll M, Cuffie C, Gagne C, Jacobson MS, Kwiterovich PO, Lee R, Lowe RS, Massaad R, McCrindle BW, Musliner TA, Triscari J, Kastelein JJ. Efficacy and safety of ezetimibe monotherapy in children with heterozygous familial or nonfamilial hypercholesterolemia. J Pediatr. 2015 Jun;166(6):1377-84.e1-3. doi: 10.1016/j.jpeds.2015.02.043. Epub 2015 Apr 1.
- 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 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 8 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. Some participants in this study may receive a placebo. 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 30 May 2013). 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?
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline and Week 12). 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 NCT00867165, 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 21 May 2024.