HypercholesterolemiaPhase 3NCT00457275
Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)
A Phase 3 study testing MK0653, ezetimibe / Duration of Treatment: 4 Weeks in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MK0653, ezetimibe / Duration of Treatment: 4 Weeks
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Nov 2005
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women >18 and <80 years of age
- Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1
- Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study
- Liver enzyme levels less than or equal to 1.5 times the upper limit of normal with no active liver disease and CPK less than or equal to 1.5 times upper limit of normal at visit 1
Who cannot join
- Cardiovascular medications, such as beta-blockers, calcium-channel blockers,
- angiotensin ii receptor antagonists or anticoagulants (i.e., warfarin) unless
- treated with a stable regimen for at least 6 weeks prior to randomization and
- patient agrees to remain on constant regimen for the duration of the study
- Patients on amiodarone hydrochloride will also be excluded
- General weight less than 50% of ideal body weight according to the 1983 metropolitan height and weight tables or weighing less than 100 lbs (45 kg)
Show all 19Show fewer
- Hypersensitivity to HMG-COA reductase inhibitors
- Patient has congestive heart failure defined by nyha class III or IV, uncontrolled cardiac arrhythmias, unstable angina pectoris, or myocardial infarction; coronary artery bypass surgery, or angioplasty within 3 months of visit 1
- Taking lipid-lowering agents including fish oils, cholestin, bile-acid sequestrants
- and niacin (grater than 200 mg/day) taken within 6 weeks and fibrates taken within 8 weeks prior to visit 1
- Taking medications that are potent inhibitors of cyp3a4, including cyclosporine,
- systemic itraconazole or ketoconazole, erythromycin or clarithromycin,
- nefazodone, verapamil and protease inhibitors
- Consumption of greater than 250 ml of grapefruit juice/day
- Taking oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to visit 1
- Treatment with psyllium, other fiber-based laxatives, and/or OTC therapies
- known to affect serum lipid levels, phytosterol margarines, unless treated with
- a stable regimen for at least 6 weeks prior to visit 1 and patient agrees to remain on constant regimen for the duration of the study
- Women who are pregnant or lactating
About this study
Official title: A Multicentre, Open-Label, Observational Local Study to Evaluate the LDL-C Lowering Effect of Ezetimibe as Prescribed in Daily Routine Practice in the South African Population
To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.
- Conditions
- Hypercholesterolemia
- Being tested
- MK0653, ezetimibe / Duration of Treatment: 4 Weeks
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0653, ezetimibe / Duration of Treatment: 4 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2005
- Primary completionNov 2005
- Study completionNov 2005
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
- Single group
- Masking
- None (open label)
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457275
- Sponsor's protocol ID
- 0653-070
- Other IDs
- 2007_012
- Status last verified
- Feb 2022
- First submitted
- 5 Apr 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Raal F, Schamroth C, Patel J, Becker P. A multicentre, open-label, observational local study to evaluate the low-density lipoprotein cholesterol-lowering effect of ezetimibe as prescribed in daily routine practice in the South African population. Cardiovasc J Afr. 2007 Sep-Oct;18(5):325-9.
PubMed 17985033
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-Label, Observational Local Study to Evaluate the LDL-C Lowering Effect of Ezetimibe as Prescribed in Daily Routine Practice in the South African Population
- ClinicalTrials.gov ID
- NCT00457275
- Acronym / sponsor ID
- 0653-070
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 6 Apr 2007 (estimated)
- 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.
To evaluate the LDL-C lowering in south african patients with primary hypercholesterolaemia after the addition of ezetimibe 10mg /day to ongoing therapy with a statin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women >18 and <80 years of age
- Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1
- Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study
- Liver enzyme levels less than or equal to 1.5 times the upper limit of normal with no active liver disease and CPK less than or equal to 1.5 times upper limit of normal at visit 1
Key exclusion criteria (19 listed)
- Cardiovascular medications, such as beta-blockers, calcium-channel blockers,
- angiotensin ii receptor antagonists or anticoagulants (i.e., warfarin) unless
- treated with a stable regimen for at least 6 weeks prior to randomization and
- patient agrees to remain on constant regimen for the duration of the study
- Patients on amiodarone hydrochloride will also be excluded
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 |
|---|---|---|
| MK0653, ezetimibe / Duration of Treatment: 4 Weeks | Drug | – |
Primary outcome
Approval
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 15 Aug 2024.
- Results publication: PubMed 17985033Raal F, Schamroth C, Patel J, Becker P. A multicentre, open-label, observational local study to evaluate the low-density lipoprotein cholesterol-lowering effect of ezetimibe as prescribed in daily routine practice in the South African population. Cardiovasc J Afr. 2007 Sep-Oct;18(5):325-9.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0653, ezetimibe / Duration of Treatment: 4 Weeks 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 19 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 15 Aug 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?
Approval. 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 NCT00457275, 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 15 Aug 2024.