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)

Phase 3

Completed

• Conditions: Hyperlipidemia; Mixed Dyslipidemia
• Interventions: Drug: Niacin ER/Simvastatin Tablets; Drug: atorvastatin

• Registration Number: NCT00465088
• Lead Sponsor: Abbott

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-24
• Primary Completion: 2008-02
• Results First Submitted: 2009-02-10
• Results First Submitted QC: 2009-03-27
• Results First Posted: 2009-05-13
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Niacin ER/Simvastatin Tablets	-
2	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12	From baseline to Week 12	(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

Secondary Outcome Measures

Name	Time	Method
Percent Change in HDL-C From Baseline to Week 8	From baseline to Week 8	(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C
Percent Change in Non-HDL-C From Baseline to Week 8	From baseline to Week 8	(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Percent Change in Non-HDL-C From Baseline to Week 12	From baseline to Week 12	(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12	From baseline to Week 12	(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C
Percent Change in Triglycerides From Baseline to Week 12	From baseline to Week 12	(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides
Percent Change in LDL-C:HDL-C Ratio	From baseline to Week 12	(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio
Percent Change in Total Cholesterol From Baseline to Week 12	From baseline to Week 12	(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol
Percent Change in Total Cholesterol:HDL-C Ratio	From baseline to Week 12	(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio
Percent Change in Lipoprotein A From Baseline to Week 12	From baseline to Week 12	(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A
Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12	12 weeks
Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12	12 weeks	For high-risk patients (coronary heart disease or equivalent), LDL-C \< 100 mg/dL and non-HDL-C \< 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C \< 130 mg/dL and non-HDL-C \< 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C \< 160 mg/dL and non-HDL-C \< 190 mg/dL.
Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12	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	12 weeks	NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C \< 100 mg/dL; for moderate risk patients, LDL-C \< 130 mg/dL; for low-risk patients: LDL-C \< 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.