MK0354 Clinical Efficacy and Tolerability Study (0354-004)

Study Overview
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Brief Summary
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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).

Official Title
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Proprietary Information - Exploratory (Non-Confirmatory) Trial

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: MK0354


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0354|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proprietary information - exploratory (non-confirmatory) trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proprietary information - exploratory (non-confirmatory) trial |  |  |