HypercholesterolemiaPhase 3NCT03885921
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
A Phase 3 study testing Ezetimibe, Atorvastatin and Simvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months 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
- Hypercholesterolemia
- What is being tested?
- Ezetimibe, Atorvastatin and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2000to 8 Jul 2003
- 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
- Has successfully completed the 12-week double-blind, efficacy and safety study of ezetimibe (Study P01030/MK-0653-018). Entry into this protocol must occur at the time of completion of Study P01030/MK-0653-018.
- All women 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. In addition, participants administered a statin must agree to practice an effective barrier method of birth control for 30 days following the last dose of statin administered.
- 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 study period.
- Is willing to observe the National Cholesterol Education Program (NCEP) Step I diet for the duration of the study.
- Is willing to participate in the study and to complete all assessments.
- Patients or in the case of children, their parents or legal guardians, must agree to give written informed consent.
Who cannot join
- Participants who discontinued prematurely from Study P01030/MK-0653-018.
- Participants who are in a situation or have any condition which, in the opinion of the Investigator, may interfere with optimal participation in the study.
- Pregnant or lactating women.
- Participants who are known to be human immunodeficiency virus (HIV) positive.
- Participants who are taking any prohibited concomitant medications. Prohibited medications include:
- Fibric Acid Derivatives;
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- Oral corticosteroids;
- (Cardiovascular drugs such as beta blockers, calcium channel blockers, angiotensin-converting enzyme [ACE] inhibitors, nitrates or alpha-adrenergic blockers or thiazide diuretics will be allowed, provided the dose will remain constant throughout the duration of the study. Acetylsalicylic acid administered as a platelet aggregation inhibitor or analgesic is permitted.);
- Treatment with psyllium or other fiber-based laxatives unless treated with a stable regimen treatment throughout the duration of the study period;
- Treatment with cyclosporine;
- Treatment with orlistat;
- Treatment with troglitazone (Rezulin®) or other thiazolidinedione antidiabetic agents, unless treated with a stable regimen throughout the duration of the study period;
- Treatment with agents with known drug interactions with simvastatin or atorvastatin including antifungal azoles (e.g. itraconazole and ketoconazole), macrolide antibiotics (e.g. erythromycin and clarithromycin) and nefazodone; In addition, treatment with other agents that may interfere with or induce the CYP3A4 isoenzyme of the cytochrome P450 system should be avoided, although they are not necessarily prohibited medications.;
- Treatment with medications which interact with simvastatin through uncertain mechanisms, including amiodarone and verapamil, are prohibited in participants administered simvastatin in this protocol.
- (Participants receiving LDL-C apheresis may continue on this therapy provided that they are on a stable regimen throughout the duration of the study and lipid levels for study visits are drawn just prior to an apheresis treatment session.);
- Participants on a stable regimen of resin therapy (as defined by the dose taken during the P01030/MK-0653-018 study) may continue that therapy provided that the daily dose of study treatment is taken ≥4 hours prior to the administration of the resin or ≥4 hours following any resin dose. In addition, the dose of resin should be taken no less than 4 hours before and no less than 4 hours after administration of study treatment.
About this study
Official title: Long-Term, Open-Label, Safety and Tolerability Study of SCH 58235 in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in participants with homozygous familial hypercholesterolemia (FH).
Following completion of the 12-week, double-blind, efficacy and safety parent study (P01030/MK-0653-018; NCT03884452) participants will be offered entry into this open-label, 24-month extension study.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe, Atorvastatin, Simvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called ZETIA®, SCH 058235, MK-0653
oral tablet
AtorvastatinDrug
Also called LIPITOR®, SCH 412387, MK-9396
oral tablet
SimvastatinDrug
Also called ZOCOR®, SCH 057098, MK-0733
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe+Atorvastatin | Experimental | Participants receive ezetimibe 10 mg via oral tablet once daily co-administered with atorvastatin 40 mg (starting dose) via oral tablet once daily in the morning (may be titrated up to a maximum daily dose of 80 mg for atorvastatin, if needed) for up to 24 months. Receives: Drug: Ezetimibe; Drug: Atorvastatin |
| Ezetimibe+Simvastatin | Experimental | Participants receive ezetimibe 10 mg via oral tablet once daily co-administered with simvastatin 40 mg (starting dose) via oral tablet once daily in the evening (may be titrated up to a maximum daily dose of 80 mg for simvastatin, if needed) for up to 24 months. Receives: Drug: Ezetimibe; Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
Measured: Up to 24 Months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Measured: Up to 24 Months
Secondary outcomes (4)
Mean Percent Change from Baseline in Low-density-lipoprotein Cholesterol (LDL-C)
Measured: Baseline and Month 24
Mean Percent Change from Baseline in Total Cholesterol (TC)
Measured: Baseline and Month 24
Mean Percent Change from Baseline in High-density-lipoprotein Cholesterol (HDL-C)
Measured: Baseline and Month 24
Mean Percent Change from Baseline in Triglycerides (TG)
Measured: Baseline and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Oct 2000
- Primary completion8 Jul 2003
- Study completion8 Jul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 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
- NCT03885921
- Sponsor's protocol ID
- P01417
- Other IDs
- P01417, MK-0653-019
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term, Open-Label, Safety and Tolerability Study of SCH 58235 in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03885921
- Acronym / sponsor ID
- P01417
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2000 (actual)
- Primary completion
- 8 Jul 2003 (actual)
- Study completion
- 8 Jul 2003 (actual)
- First posted
- 22 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 purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in participants with homozygous familial hypercholesterolemia (FH).
Following completion of the 12-week, double-blind, efficacy and safety parent study (P01030/MK-0653-018; NCT03884452) participants will be offered entry into this open-label, 24-month extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe+Atorvastatin | Experimental | Drug: Ezetimibe, Drug: AtorvastatinParticipants receive ezetimibe 10 mg via oral tablet once daily co-administered with atorvastatin 40 mg (starting dose) via oral tablet once daily in the morning (may be titrated up to a maximum daily dose of 80 mg for atorvastatin, if needed) for up to 24 months. |
| Ezetimibe+Simvastatin | Experimental | Drug: Ezetimibe, Drug: SimvastatinParticipants receive ezetimibe 10 mg via oral tablet once daily co-administered with simvastatin 40 mg (starting dose) via oral tablet once daily in the evening (may be titrated up to a maximum daily dose of 80 mg for simvastatin, if needed) for up to 24 months. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has successfully completed the 12-week double-blind, efficacy and safety study of ezetimibe (Study P01030/MK-0653-018). Entry into this protocol must occur at the time of completion of Study P01030/MK-0653-018.
- All women 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. In addition, participants administered a statin must agree to practice an effective barrier method of birth control for 30 days following the last dose of statin administered.
- 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 study period.
- Is willing to observe the National Cholesterol Education Program (NCEP) Step I diet for the duration of the study.
- Is willing to participate in the study and to complete all assessments.
Key exclusion criteria (16 listed)
- Participants who discontinued prematurely from Study P01030/MK-0653-018.
- Participants who are in a situation or have any condition which, in the opinion of the Investigator, may interfere with optimal participation in the study.
- Pregnant or lactating women.
- Participants who are known to be human immunodeficiency virus (HIV) positive.
- Participants who are taking any prohibited concomitant medications. Prohibited medications include:
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: ZETIA®, SCH 058235, MK-0653oral tablet | Drug | Ezetimibe+Atorvastatin, Ezetimibe+Simvastatin |
| AtorvastatinAlso: LIPITOR®, SCH 412387, MK-9396oral tablet | Drug | Ezetimibe+Atorvastatin |
| SimvastatinAlso: ZOCOR®, SCH 057098, MK-0733oral tablet | Drug | Ezetimibe+Simvastatin |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 24 Months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Time frame: Up to 24 Months
4 secondary outcomes
Mean Percent Change from Baseline in Low-density-lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in Total Cholesterol (TC)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in High-density-lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Month 24
Mean Percent Change from Baseline in Triglycerides (TG)
Time frame: Baseline and Month 24
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 17 Feb 2022.
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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 Ezetimibe, Atorvastatin and Simvastatin in people with 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 6 inclusion and 16 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 17 Feb 2022. 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?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to 24 Months). 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?
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 17 Feb 2022.