HypercholesterolemiaPhase 4NCT00652444
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
A Phase 4 study testing ezetimibe and simvastatin in people with Hypercholesterolemia, run by Organon and Co.
Trial summary
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- ezetimibe and simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Aug 2004
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
- Age of at least 18 years and 75 years or less
- Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l
Who cannot join
- Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
- Uncontrolled cardiac arrhythmias
- Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
- History of unstable or severe peripheral artery disease within 3 months of study entry
- Uncontrolled hypertension at study entry
- Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
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- Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
- Active or chronic hepatic and hepatobiliary disease
- Disorders that would limit study evaluation or participation
About this study
Official title: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
- Conditions
- Hypercholesterolemia
- Being tested
- ezetimibe, simvastatin, Placebo (Unspecified)
- 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®, EZETROL®, MK0653
ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6.
simvastatinDrug
Also called Zocor®, MK0733
simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6.
Placebo (Unspecified)Drug
Matching ezetimibe placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Coadministration arm: simvastatin 20mg and ezetimibe 10mg Receives: Drug: ezetimibe; Drug: simvastatin |
| 2 | Experimental | Monotherapy arm: simvastatin 20mg and ezetimibe placebo Receives: Drug: simvastatin; Drug: Placebo (Unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction of LDL-C after 6 weeks of treatment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startSep 2003
- Primary completionAug 2004
- Study completionAug 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
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
- NCT00652444
- Sponsor's protocol ID
- 0653-151
- Other IDs
- 2008_004
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 18 Feb 2022
- Results posted
- No
Publications
Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
PubMed 18545068
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00652444
- Acronym / sponsor ID
- 0653-151
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 3 Apr 2008 (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.
The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ezetimibe, Drug: simvastatinCoadministration arm: simvastatin 20mg and ezetimibe 10mg |
| 2 | Experimental | Drug: simvastatin, Drug: Placebo (Unspecified)Monotherapy arm: simvastatin 20mg and ezetimibe placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
- Age of at least 18 years and 75 years or less
- Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l
Key exclusion criteria (9 listed)
- Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
- Uncontrolled cardiac arrhythmias
- Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
- History of unstable or severe peripheral artery disease within 3 months of study entry
- Uncontrolled hypertension at study entry
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®, EZETROL®, MK0653ezetimibe 10mg. Blood samples were collected again at the end of study treatment, week 6. | Drug | 1 |
| simvastatinAlso: Zocor®, MK0733simvastatin 20mg . Blood samples were collected again at the end of study treatment, week 6. | Drug | 1, 2 |
| Placebo (Unspecified)Matching ezetimibe placebo | Drug | 2 |
Primary outcome
Percentage reduction of LDL-C after 6 weeks of treatment.
Time frame: 6 weeks
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 18 Feb 2022.
- Background: PubMed 18545068Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
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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 4 study testing ezetimibe 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 3 inclusion and 9 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 18 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 reduction of LDL-C after 6 weeks of treatment. (time frame: 6 weeks). 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 NCT00652444, 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 18 Feb 2022.