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)

Hyperlipidemia Clinical Trial

— SUPREME  

Official title:

SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465088
• Other study ID #: 019-05-06-CR
• Secondary ID: M10-013
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2007
• Last updated: June 9, 2011
• Start date: April 2007

Study information

• Verified date: June 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Mixed Dyslipidemia

Intervention

Drug:
• Niacin ER/Simvastatin Tablets
Up to 2000 mg/40 mg at bedtime
• atorvastatin
40 mg at bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12	(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C	From baseline to Week 12	No
Secondary	Percent Change in HDL-C From Baseline to Week 8	(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C	From baseline to Week 8	No
Secondary	Percent Change in Non-HDL-C From Baseline to Week 8	(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C	From baseline to Week 8	No
Secondary	Percent Change in Non-HDL-C From Baseline to Week 12	(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C	From baseline to Week 12	No
Secondary	Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12	(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C	From baseline to Week 12	No
Secondary	Percent Change in Triglycerides From Baseline to Week 12	(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides	From baseline to Week 12	No
Secondary	Percent Change in LDL-C:HDL-C Ratio	(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio	From baseline to Week 12	No
Secondary	Percent Change in Total Cholesterol From Baseline to Week 12	(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol	From baseline to Week 12	No
Secondary	Percent Change in Total Cholesterol:HDL-C Ratio	(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio	From baseline to Week 12	No
Secondary	Percent Change in Lipoprotein A From Baseline to Week 12	(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A	From baseline to Week 12	No
Secondary	Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12		12 weeks	No
Secondary	Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12	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.	12 weeks	No
Secondary	Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12		12 weeks	No
Secondary	Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12	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.	12 weeks	No