Familial HypercholesterolemiaPhase 3NCT03884452
Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
A Phase 3 study testing Atorvastatin, Simvastatin and Ezetimibe in people with Familial Hypercholesterolemia, run by Organon and Co.
Trial summary
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Atorvastatin, Simvastatin and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2000to 24 May 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- With a diagnosis of homozygous familial hypercholesterolemia
- All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment.
- Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period.
- Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries
Who cannot join
- A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study.
- With underlying disease likely to limit life span to less than 1 year.
- Have previously been randomized in any studies examining ezetimibe
- Pregnant or lactating women.
- With known hypersensitivity or any contraindication to statin therapy.
About this study
Official title: A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Atorvastatin, Simvastatin, Ezetimibe, Placebo for Ezetimibe
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Tablets taken orally once daily in the morning
SimvastatinDrug
Tablets taken orally once daily in the morning or evening
EzetimibeDrug
Tablet taken orally once daily in the morning or evening
Placebo for EzetimibeDrug
Tablets taken orally once daily in the morning or evening
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 80 mg | Experimental | 80 mg atorvastatin taken orally, once daily for 12 weeks Receives: Drug: Atorvastatin; Drug: Placebo for Ezetimibe |
| Ezetimibe + Atorvastatin 40 mg | Experimental | 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks Receives: Drug: Atorvastatin; Drug: Ezetimibe |
| Ezetimibe + Atorvastatin 80 mg | Experimental | 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks Receives: Drug: Atorvastatin; Drug: Ezetimibe |
| Simvastatin 80 mg | Experimental | 80 mg simvastatin taken orally, once daily for 12 weeks Receives: Drug: Simvastatin; Drug: Placebo for Ezetimibe |
| Ezetimibe + Simvastatin 40 mg | Experimental | 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks Receives: Drug: Simvastatin; Drug: Ezetimibe |
| Ezetimibe + Simvastatin 80 mg | Experimental | 10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks Receives: Drug: Simvastatin; Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly
Measured: Baseline and Up to Week 12
Percentage of participants with an Adverse Event (AE)
Measured: Up to Week 12
Secondary outcomes (9)
Percent change from baseline in calculated LDL-C
Measured: Baseline and Up to Week 12
Percent change from baseline in Total Cholesterol (TC)
Measured: Baseline and Up to Week 12
Percent change from baseline in Triglycerides (TG)
Measured: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)
Measured: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)
Measured: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)
Measured: Baseline and Up to Week 12
Percent change from baseline in Apolipoprotein A-I (Apo A-I)
Measured: Baseline and Up to Week 12
Percent change from baseline in Apolipoprotein B (Apo B)
Measured: Baseline and Up to Week 12
Percent change from baseline in Lipoprotein(a) [Lp(a)]
Measured: Baseline and Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start3 May 2000
- Primary completion24 May 2001
- Study completion24 May 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884452
- Sponsor's protocol ID
- P01030
- Other IDs
- P01030, MK-0653-018
- Status last verified
- Feb 2022
- First submitted
- 6 Mar 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62.
PubMed 12034651
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03884452
- Acronym / sponsor ID
- P01030
- Conditions
- Familial Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 3 May 2000 (actual)
- Primary completion
- 24 May 2001 (actual)
- Study completion
- 24 May 2001 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 80 mg | Experimental | Drug: Atorvastatin, Drug: Placebo for Ezetimibe80 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 40 mg | Experimental | Drug: Atorvastatin, Drug: Ezetimibe10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 80 mg | Experimental | Drug: Atorvastatin, Drug: Ezetimibe10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks |
| Simvastatin 80 mg | Experimental | Drug: Simvastatin, Drug: Placebo for Ezetimibe80 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 40 mg | Experimental | Drug: Simvastatin, Drug: Ezetimibe10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 80 mg | Experimental | Drug: Simvastatin, Drug: Ezetimibe10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- With a diagnosis of homozygous familial hypercholesterolemia
- All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment.
- Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period.
- Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries
Key exclusion criteria (5 listed)
- A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study.
- With underlying disease likely to limit life span to less than 1 year.
- Have previously been randomized in any studies examining ezetimibe
- Pregnant or lactating women.
- With known hypersensitivity or any contraindication to statin therapy.
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 |
|---|---|---|
| AtorvastatinTablets taken orally once daily in the morning | Drug | Atorvastatin 80 mg, Ezetimibe + Atorvastatin 40 mg, Ezetimibe + Atorvastatin 80 mg |
| SimvastatinTablets taken orally once daily in the morning or evening | Drug | Ezetimibe + Simvastatin 40 mg, Ezetimibe + Simvastatin 80 mg, Simvastatin 80 mg |
| EzetimibeTablet taken orally once daily in the morning or evening | Drug | Ezetimibe + Atorvastatin 40 mg, Ezetimibe + Atorvastatin 80 mg, Ezetimibe + Simvastatin 40 mg, Ezetimibe + Simvastatin 80 mg |
| Placebo for EzetimibeTablets taken orally once daily in the morning or evening | Drug | Atorvastatin 80 mg, Simvastatin 80 mg |
Primary outcome
Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly
Time frame: Baseline and Up to Week 12
Percentage of participants with an Adverse Event (AE)
Time frame: Up to Week 12
9 secondary outcomes
Percent change from baseline in calculated LDL-C
Time frame: Baseline and Up to Week 12
Percent change from baseline in Total Cholesterol (TC)
Time frame: Baseline and Up to Week 12
Percent change from baseline in Triglycerides (TG)
Time frame: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C)
Time frame: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C)
Time frame: Baseline and Up to Week 12
Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C)
Time frame: Baseline and Up to Week 12
Percent change from baseline in Apolipoprotein A-I (Apo A-I)
Time frame: Baseline and Up to Week 12
Percent change from baseline in Apolipoprotein B (Apo B)
Time frame: Baseline and Up to Week 12
Percent change from baseline in Lipoprotein(a) [Lp(a)]
Time frame: Baseline and Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 12034651Gagne C, Gaudet D, Bruckert E; Ezetimibe Study Group. Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation. 2002 May 28;105(21):2469-75. doi: 10.1161/01.cir.0000018744.58460.62.
- 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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin, Simvastatin and Ezetimibe in people with Familial 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 4 inclusion and 5 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 10 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly (time frame: Baseline and Up to Week 12). The study lists 2 primary outcomes in all. 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 NCT03884452, 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 10 May 2024.