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)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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.
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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
- Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion
Trial design
Primary purpose
Allocation
Interventional model
Masking
199 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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