DyslipidemiaPhase 2NCT00337415
MK0354 Clinical Efficacy and Tolerability Study (0354-004)
A Phase 2 study testing MK0354 in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood) This is an early phase trial and some specific protocol information is proprietary and not publicly available at… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- MK0354
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Aug 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 75 years of age
- You have taken a statin or other lipid modifying therapy in the last 6-8 weeks
- You have lipid lab values outside of the range specified in the protocol
Who cannot join
- Patient is a woman who is pregnant or nursing a child
- Patient is a woman who is taking hormonal birth-control
- You are a woman who is planning to donate eggs during the study
- You plan to give blood during the study or have given within the last 8 weeks
- You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes
- You have a known intolerance to or you are allergic to niacin
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- You have any of the following medical conditions:
- Poorly controlled or newly diagnosed diabetes (within the last 3 months)
- Thyroid disease (hypothyroidism or hyperthyroidism)
- A history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months
- History of hemorrhagic stroke or other non-traumatic hemorrhage
- Peptic ulcer disease in the last 3 months
- An occurrence of gout within the last year and you are not currently taking allopurinol
- Cancer (except for successfully treated skin cancer)
- HIV positive
- You have a history of drug/alcohol abuse within the last year
- You consume more than 2 drinks of alcohol per day
- You do not have access to a telephone
- You take medications that are not allowed in this study. The study doctor or staff will discuss this with you.
- Patient has participated in a study with an investigational drug within the last 30 days
About this study
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
A Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood)
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
- Conditions
- Dyslipidemia
- Being tested
- MK0354
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0354Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
proprietary information - exploratory (non-confirmatory) trial
Secondary outcomes (1)
proprietary information - exploratory (non-confirmatory) trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Enrolment
- 65 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
- NCT00337415
- Sponsor's protocol ID
- 0354-004
- Status last verified
- May 2015
- First submitted
- 14 Jun 2006
- Last updated
- 18 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprietary Information - Exploratory (Non-Confirmatory) Trial
- ClinicalTrials.gov ID
- NCT00337415
- Acronym / sponsor ID
- 0354-004
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 16 Jun 2006 (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 Research Study to Evaluate the Effectiveness and Tolerability of MK0354 vs Placebo (an inactive look alike pill) in Lipid (fat) Altering in Patients with dyslipidemia (a disorder of lipids in the blood)
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is between 18 and 75 years of age
- You have taken a statin or other lipid modifying therapy in the last 6-8 weeks
- You have lipid lab values outside of the range specified in the protocol
Key exclusion criteria (20 listed)
- Patient is a woman who is pregnant or nursing a child
- Patient is a woman who is taking hormonal birth-control
- You are a woman who is planning to donate eggs during the study
- You plan to give blood during the study or have given within the last 8 weeks
- You are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes
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 |
|---|---|---|
| MK0354 | Drug | – |
Primary outcome
proprietary information - exploratory (non-confirmatory) trial
1 secondary outcome
proprietary information - exploratory (non-confirmatory) trial
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 18 May 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 MK0354 in people with 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 3 inclusion and 20 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 18 May 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. 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?
proprietary information - exploratory (non-confirmatory) trial. 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 18 May 2015.