Status:
TERMINATED
MK0354 Clinical Efficacy and Tolerability Study (0354-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 bl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00337415
Start Date
May 1 2006
End Date
August 1 2006
Last Update
May 18 2015
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