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)
NCT ID: NCT00465088
Last Updated: 2011-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Niacin ER/Simvastatin Tablets
Up to 2000 mg/40 mg at bedtime
2
atorvastatin
40 mg at bedtime
Interventions
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Niacin ER/Simvastatin Tablets
Up to 2000 mg/40 mg at bedtime
atorvastatin
40 mg at bedtime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HDL-C \<40 mg/dL for men and \<50 mg/dL for women.
* LDL-C ≥130 mg/dL but \<250 mg/dL.
* TG \<350 mg/dL.
* Creatine phosphokinase (CPK) \< 3 x upper limit of normal (ULN).
* Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase \[SGPT\] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase \[SGOT\] \< 1.3 x ULN.
* Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Roopal Thakkar, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Anaheim, California, United States
Huntington Park, California, United States
Long Beach, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Brooksville, Florida, United States
Daytona Beach, Florida, United States
Gainesville, Florida, United States
Largo, Florida, United States
Merritt Island, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Calhoun, Georgia, United States
Decatur, Georgia, United States
Dunwoody, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Arkansas City, Kansas, United States
Newton, Kansas, United States
Shawnee Mission, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
Missoula, Montana, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Canfield, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Protland, Oregon, United States
Chicora, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Magna, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Gig Harbor, Washington, United States
Menomonee Falls, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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M10-013
Identifier Type: -
Identifier Source: secondary_id
019-05-06-CR
Identifier Type: -
Identifier Source: org_study_id
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