An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Anaheim, California, 92801 | Status Not Available | |
Location Huntington Park, California, 90255 | Status Not Available | |
Location Long Beach, California, 90822 | Status Not Available | |
Location Sacramento, California, 95825 | Status Not Available | |
Location Walnut Creek, California, 94598 | Status Not Available | |
Location Brooksville, Florida, 34613 | Status Not Available | |
Location Daytona Beach, Florida, 32117 | Status Not Available | |
Location Gainesville, Florida, 32605 | Status Not Available | |
Location Largo, Florida, 33770 | Status Not Available | |
Location Merritt Island, Florida, 32953 | Status Not Available | |
Location Miami, Florida, 33126 | Status Not Available | |
Location Pembroke Pines, Florida, 33026 | Status Not Available | |
Location Calhoun, Georgia, 30701 | Status Not Available | |
Location Decatur, Georgia, 30034 | Status Not Available | |
Location Dunwoody, Georgia, 30338 | Status Not Available | |
Location Boise, Idaho, 83704 | Status Not Available | |
Location Chicago, Illinois, 60607 | Status Not Available | |
Location Arkansas City, Kansas, 67005 | Status Not Available | |
Location Newton, Kansas, 67114 | Status Not Available | |
Location Shawnee Mission, Kansas, 66216 | Status Not Available | |
Location Topeka, Kansas, 55508 | Status Not Available | |
Location Wichita, Kansas, 67203 | Status Not Available | |
Location Auburn, Maine, 04210 | Status Not Available | |
Location Baltimore, Maryland, 21204 | Status Not Available | |
Location Missoula, Montana, 59808 | Status Not Available | |
Location Charlotte, North Carolina, 28204 | Status Not Available | |
Location High Point, North Carolina, 27262 | Status Not Available | |
Location Canfield, Ohio, 44406 | Status Not Available | |
Location Cincinnati, Ohio, 45242 | Status Not Available | |
Location Dayton, Ohio, 45458 | Status Not Available | |
Location Protland, Oregon, 97239 | Status Not Available | |
Location Chicora, Pennsylvania, 16025 | Status Not Available | |
Location Duncansville, Pennsylvania, 16635 | Status Not Available | |
Location Harleysville, Pennsylvania, 19438 | Status Not Available | |
Location Pittsburgh, Pennsylvania, 15206 | Status Not Available | |
Location Austin, Texas, 78752 | Status Not Available | |
Location Carrollton, Texas, 75006 | Status Not Available | |
Location Dallas, Texas, 75251 | Status Not Available | |
Location Houston, Texas, 77074 | Status Not Available | |
Location San Antonio, Texas, 78224 | Status Not Available | |
Location Magna, Utah, 84044 | Status Not Available | |
Location Salt Lake City, Utah, 84107 | Status Not Available | |
Location Richmond, Virginia, 23249 | Status Not Available | |
Location Gig Harbor, Washington, 98335 | Status Not Available | |
Location Menomonee Falls, Wisconsin, 53051 | Status Not Available | |
Location Milwaukee, Wisconsin, 53209 | Status Not Available |
To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
Time Frame: From baseline to Week 12
Percent Change in HDL-C From Baseline to Week 8
Time Frame: From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 8
Time Frame: From baseline to Week 8
Percent Change in Non-HDL-C From Baseline to Week 12
Time Frame: From baseline to Week 12
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
Time Frame: From baseline to Week 12
Percent Change in Triglycerides From Baseline to Week 12
Time Frame: From baseline to Week 12
Percent Change in LDL-C:HDL-C Ratio
Time Frame: From baseline to Week 12
Percent Change in Total Cholesterol From Baseline to Week 12
Time Frame: From baseline to Week 12
Percent Change in Total Cholesterol:HDL-C Ratio
Time Frame: From baseline to Week 12
Percent Change in Lipoprotein A From Baseline to Week 12
Time Frame: From baseline to Week 12
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
Time Frame: 12 weeks
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
Time Frame: 12 weeks
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
Time Frame: 12 weeks
Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
Time Frame: 12 weeks
Interventions:
- Drug: Niacin ER/Simvastatin Tablets
- Drug: atorvastatin
Enrollment:
199
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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