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: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Atorvastatin; Atorvastatin Calcium; Niacin; Niacinamide; Nicotinic Acids; Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion