Hyperlipidemia Clinical Trial
Official title:
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Study to Evaluate the Efficacy of MK0524 to Improve Tolerability of Extended Release Niacin
Verified date | February 2017 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 be 6 scheduled clinic visits and 3 treatment arms.
Status | Completed |
Enrollment | 825 |
Est. completion date | January 2007 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Flushing Severity Score (GFSS) during 7 days of treatment | during 7 days of treatment | ||
Secondary | Percentage of Participants Who Experience at Least 1 Adverse Event | up to 10 weeks | ||
Secondary | Percentage of Participants Who Were Discontinued from the Study Due to an Adverse Event | up to 10 weeks |
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