AtherosclerosisPhase 2NCT00421278
The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)
A Phase 2 study testing MK0633 in people with Atherosclerosis, run by Merck Sharp & Dohme LLC.
Trial summary
A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- MK0633
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2007
- Phase
- Phase 2
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
- Inflammatory marker found in your blood, known as hsCRP > 0.5 mg/L
Who cannot join
- Age < 40 or > 85
- Female
- Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
- Liver diseased or abnormalities
- HIV infection
- Lupus, rheumatoid arthritis, cancer <5 years
About this study
Official title: A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis
A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease
- Conditions
- Atherosclerosis
- Being tested
- MK0633
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0633Drug
Single dose MK0633 100mg po in the fed state administered during a 4-wk study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1: Drug Receives: Drug: MK0633 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00421278
- Sponsor's protocol ID
- 0633-008
- Other IDs
- MK0633-008, 2006_563
- Status last verified
- Jan 2016
- First submitted
- 9 Jan 2007
- Last updated
- 22 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy and Safety of MK0633 in Patients With Atherosclerosis
- ClinicalTrials.gov ID
- NCT00421278
- Acronym / sponsor ID
- 0633-008
- Conditions
- Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Jan 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.
A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK0633Arm 1: Drug |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease
- Inflammatory marker found in your blood, known as hsCRP > 0.5 mg/L
Key exclusion criteria (6 listed)
- Age < 40 or > 85
- Female
- Heart attack, coronary artery bypass, stroke or unstable angina in last 3 months
- Liver diseased or abnormalities
- HIV infection
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 |
|---|---|---|
| MK0633Single dose MK0633 100mg po in the fed state administered during a 4-wk study. | Drug | 1 |
Primary outcome
To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis
Time frame: 4 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 22 Jan 2016.
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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 2 study testing MK0633 in people with Atherosclerosis, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 6 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 22 Jan 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the effects of the drug, MK 0633, on an inflammatory marker in your blood that may affect the plaque in the arteries, know as atherosclerosis (time frame: 4 Weeks). 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 22 Jan 2016.