CholesterolPhase 3NCT00652301
A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)
A Phase 3 study testing ezetimibe and simvastatin in people with Cholesterol, run by Organon and Co.
Trial summary
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cholesterol
- What is being tested?
- ezetimibe and simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Apr 2004
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between the ages of 18-55 with LDL More than 130, but less than 180
Who cannot join
- Individuals with drug or substance abuse
- Individuals with poor mental function
- Individuals having more than 14 alcoholic drinks a week
- Individuals that have been treated with any other investigational drug in the last 30 days
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
Read the detailed description
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
- Conditions
- Cholesterol
- Being tested
- ezetimibe, Comparator: Placebo (unspecified), simvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibeDrug
Also called MK0653
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Comparator: Placebo (unspecified)Drug
matching placebo tablet. Duration of Treatment 31 Weeks.
simvastatinDrug
Also called MK0733
simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ezetimibe 10 mg tablet plus simvastatin 20 mg tablet Receives: Drug: ezetimibe; Drug: simvastatin |
| 2 | Active comparator | ezetimibe 10 mg tablet Receives: Drug: ezetimibe; Drug: Comparator: Placebo (unspecified) |
| 3 | Active comparator | simvastatin 20 mg tablet Receives: Drug: Comparator: Placebo (unspecified); Drug: simvastatin |
| 4 | Placebo comparator | matching placebo Receives: Drug: Comparator: Placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
Measured: Based on 7 week treatment periods.
Secondary outcomes (1)
To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
Measured: Based on 7 week treatment periods.
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 startJul 2003
- Primary completionApr 2004
- Study completionApr 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 CholesterolStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652301
- Sponsor's protocol ID
- 0653-050
- Other IDs
- MK0653-050, 2007_559
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20.
PubMed 19380898
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 Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol
- ClinicalTrials.gov ID
- NCT00652301
- Acronym / sponsor ID
- 0653-050
- Conditions
- Cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Schering-Plough
- Study start
- Jul 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 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.
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.
Detailed description
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ezetimibe, Drug: simvastatinezetimibe 10 mg tablet plus simvastatin 20 mg tablet |
| 2 | Active comparator | Drug: ezetimibe, Drug: Comparator: Placebo (unspecified)ezetimibe 10 mg tablet |
| 3 | Active comparator | Drug: Comparator: Placebo (unspecified), Drug: simvastatinsimvastatin 20 mg tablet |
| 4 | Placebo comparator | Drug: Comparator: Placebo (unspecified)matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males between the ages of 18-55 with LDL More than 130, but less than 180
Key exclusion criteria (4 listed)
- Individuals with drug or substance abuse
- Individuals with poor mental function
- Individuals having more than 14 alcoholic drinks a week
- Individuals that have been treated with any other investigational drug in the last 30 days
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: MK0653ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. | Drug | 1, 2 |
| Comparator: Placebo (unspecified)matching placebo tablet. Duration of Treatment 31 Weeks. | Drug | 2, 3, 4 |
| simvastatinAlso: MK0733simvastatin 20 mg tablet. Duration of Treatment 31 Weeks. | Drug | 1, 3 |
Primary outcome
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone.
Time frame: Based on 7 week treatment periods.
1 secondary outcome
To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption.
Time frame: Based on 7 week treatment periods.
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 19380898Sudhop T, Reber M, Tribble D, Sapre A, Taggart W, Gibbons P, Musliner T, von Bergmann K, Lutjohann D. Changes in cholesterol absorption and cholesterol synthesis caused by ezetimibe and/or simvastatin in men. J Lipid Res. 2009 Oct;50(10):2117-23. doi: 10.1194/jlr.P900004-JLR200. Epub 2009 Apr 20.
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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 ezetimibe and simvastatin in people with Cholesterol, 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 1 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 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. 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?
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. (time frame: Based on 7 week treatment periods.). 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 NCT00652301, 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.