Status:
COMPLETED
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesteremia
Hyperlipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will b...
Eligibility Criteria
Inclusion
- Patient is appropriate candidate for niacin therapy
- Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C \<130 mg/dL at V1
- Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C \<130 mg/dL at V1
- Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C \<160 mg/dL at V1
- Patient has TG \<500 mg/dL (5.65 mmol/L) at V1
- A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
- ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA
Exclusion
- Patients with unstable doses of medications
- Pregnant or lactating women, or women intending to become pregnant are excluded
- Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
- Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT00376584
Start Date
July 1 2006
End Date
January 1 2007
Last Update
February 16 2017
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