Status:
COMPLETED
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)
Lead Sponsor:
Abbott
Conditions:
Hyperlipidemia
Mixed Dyslipidemia
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following laboratory 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
- Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00465088
Start Date
April 1 2007
Last Update
June 13 2011
Active Locations (46)
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1
Anaheim, California, United States, 92801
2
Huntington Park, California, United States, 90255
3
Long Beach, California, United States, 90822
4
Sacramento, California, United States, 95825