Metabolic X Syndrome DyslipidemiaPhase 2NCT00703690
MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)
A Phase 2 study testing MK0767 and Comparator: fenofibrate in people with Metabolic X Syndrome Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Metabolic X Syndrome Dyslipidemia
- What is being tested?
- MK0767 and Comparator: fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2003
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65
- Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP
Who cannot join
- Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease
- Patient is on cyclical estrogen medications
- Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
- Conditions
- Metabolic X Syndrome Dyslipidemia
- Being tested
- MK0767, Comparator: fenofibrate, Comparator: Placebo (unspecified)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0767Drug
MK0767 2.5, 5, and 10 mg/day supplied as tablets
Comparator: fenofibrateDrug
fenofibrate 200 mg supplied as capsules
Comparator: Placebo (unspecified)Drug
matching placebo will be supplied as tablets/capsules.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK0767; 2.5 mg/day Receives: Drug: MK0767 |
| 2 | Experimental | MK0767; 5mg/day Receives: Drug: MK0767 |
| 3 | Experimental | MK0767; 10 mg/day Receives: Drug: MK0767 |
| 4 | Active comparator | fenofibrate 200 mg Receives: Drug: Comparator: fenofibrate |
| 5 | 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.
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
Measured: After 12 weeks of treatment
Secondary outcomes (1)
MK0767 will be safe and well tolerated
Measured: throughout study and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic X Syndrome DyslipidemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 436 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
- NCT00703690
- Sponsor's protocol ID
- 0767-016
- Other IDs
- MK0767-016, 2007_641
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2008
- Last updated
- 12 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia
- ClinicalTrials.gov ID
- NCT00703690
- Acronym / sponsor ID
- 0767-016
- Conditions
- Metabolic X Syndrome Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 23 Jun 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.
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK0767MK0767; 2.5 mg/day |
| 2 | Experimental | Drug: MK0767MK0767; 5mg/day |
| 3 | Experimental | Drug: MK0767MK0767; 10 mg/day |
| 4 | Active comparator | Drug: Comparator: fenofibratefenofibrate 200 mg |
| 5 | Placebo comparator | Drug: Comparator: Placebo (unspecified)Matching Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65
- Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP
Key exclusion criteria (3 listed)
- Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease
- Patient is on cyclical estrogen medications
- Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2
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 |
|---|---|---|
| MK0767MK0767 2.5, 5, and 10 mg/day supplied as tablets | Drug | 1, 2, 3 |
| Comparator: fenofibratefenofibrate 200 mg supplied as capsules | Drug | 4 |
| Comparator: Placebo (unspecified)matching placebo will be supplied as tablets/capsules. | Drug | 5 |
Primary outcome
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
Time frame: After 12 weeks of treatment
1 secondary outcome
MK0767 will be safe and well tolerated
Time frame: throughout study and at 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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 MK0767 and Comparator: fenofibrate in people with Metabolic X Syndrome Dyslipidemia, 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 3 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: stopped early, as of the sponsor's last update on 12 Jun 2015. 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 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 was stopped early. Results are not available in the source record.
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?
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. (time frame: After 12 weeks of treatment). 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 12 Jun 2015.