HypercholesterolemiaPhase 3NCT03882892
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
A Phase 3 study testing Ezetimibe and Atovastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe and Atovastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2001to 8 Aug 2002
- 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 18 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
- If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
- If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
- Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.
Who cannot join
- Has discontinued from the parent study (P00692) prior to study completion.
- Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
- Is a pregnant or lactating female.
- Is human immunodeficiency virus (HIV) positive.
About this study
Official title: Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
Read the detailed description
This study is a long-term extension study of the protocol P00692 parent study.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe, Atovastatin, Placebo
- 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 SCH 58235
Ezetimibe 10 mg tablets
AtovastatinDrug
Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
PlaceboDrug
Placebo tablets matched to ezetimibe
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Atorvastatin | Placebo comparator | Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study. Receives: Drug: Atovastatin; Drug: Placebo |
| Ezetimibe + Atorvastatin | Experimental | Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study. Receives: Drug: Ezetimibe; Drug: Atovastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Measured: Up to 12 months
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
Measured: Up to 12 months
Secondary outcomes (5)
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Measured: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Triglyceride Levels
Measured: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Total Cholesterol (TC)
Measured: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline and 1.5, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start2 Feb 2001
- Primary completion8 Aug 2002
- Study completion8 Aug 2002
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 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
- 400 participants (estimated)
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
- NCT03882892
- Sponsor's protocol ID
- P02154
- Other IDs
- MK-0653-017, P02154
- Status last verified
- Feb 2022
- First submitted
- 19 Mar 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.
PubMed 15311720
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
- Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03882892
- Acronym / sponsor ID
- P02154
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2001 (actual)
- Primary completion
- 8 Aug 2002 (actual)
- Study completion
- 8 Aug 2002 (actual)
- First posted
- 20 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 purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
Detailed description
This study is a long-term extension study of the protocol P00692 parent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Atorvastatin | Placebo comparator | Drug: Atovastatin, Drug: PlaceboParticipants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study. |
| Ezetimibe + Atorvastatin | Experimental | Drug: Ezetimibe, Drug: AtovastatinParticipants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
- If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
- If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
- Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.
Key exclusion criteria (4 listed)
- Has discontinued from the parent study (P00692) prior to study completion.
- Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
- Is a pregnant or lactating female.
- Is human immunodeficiency virus (HIV) positive.
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 58235Ezetimibe 10 mg tablets | Drug | Ezetimibe + Atorvastatin |
| AtovastatinAtorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg | Drug | Ezetimibe + Atorvastatin, Placebo + Atorvastatin |
| PlaceboPlacebo tablets matched to ezetimibe | Drug | Placebo + Atorvastatin |
Primary outcome
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 12 months
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
Time frame: Up to 12 months
5 secondary outcomes
Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Triglyceride Levels
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Total Cholesterol (TC)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 1.5, 3, 6, 9, and 12 months
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 15311720Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.
- 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 Ezetimibe and Atovastatin 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 4 inclusion and 4 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. 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?
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?
Percentage of Participants Experiencing ≥1 Adverse Event (AE) (time frame: Up to 12 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?
On the ClinicalTrials.gov record for NCT03882892, 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.