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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)

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemia; Mixed Dyslipidemia

Intervention: Niacin ER/Simvastatin Tablets (Drug); atorvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Roopal Thakkar, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

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

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

Primary outcome: Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12

Secondary outcome:

Percent Change in HDL-C From Baseline to Week 8

Percent Change in Non-HDL-C From Baseline to Week 8

Percent Change in Non-HDL-C From Baseline to Week 12

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12

Percent Change in Triglycerides From Baseline to Week 12

Percent Change in LDL-C:HDL-C Ratio

Percent Change in Total Cholesterol From Baseline to Week 12

Percent Change in Total Cholesterol:HDL-C Ratio

Percent Change in Lipoprotein A From Baseline to Week 12

Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12

Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12

Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12

Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Anaheim, California 92801, United States

Huntington Park, California 90255, United States

Long Beach, California 90822, United States

Sacramento, California 95825, United States

Walnut Creek, California 94598, United States

Brooksville, Florida 34613, United States

Daytona Beach, Florida 32117, United States

Gainesville, Florida 32605, United States

Largo, Florida 33770, United States

Merritt Island, Florida 32953, United States

Miami, Florida 33126, United States

Pembroke Pines, Florida 33026, United States

Calhoun, Georgia 30701, United States

Decatur, Georgia 30034, United States

Dunwoody, Georgia 30338, United States

Boise, Idaho 83704, United States

Chicago, Illinois 60607, United States

Arkansas City, Kansas 67005, United States

Newton, Kansas 67114, United States

Shawnee Mission, Kansas 66216, United States

Topeka, Kansas 55508, United States

Wichita, Kansas 67203, United States

Auburn, Maine 04210, United States

Baltimore, Maryland 21204, United States

Missoula, Montana 59808, United States

Charlotte, North Carolina 28204, United States

High Point, North Carolina 27262, United States

Canfield, Ohio 44406, United States

Cincinnati, Ohio 45242, United States

Dayton, Ohio 45458, United States

Protland, Oregon 97239, United States

Chicora, Pennsylvania 16025, United States

Duncansville, Pennsylvania 16635, United States

Harleysville, Pennsylvania 19438, United States

Pittsburgh, Pennsylvania 15206, United States

Austin, Texas 78752, United States

Carrollton, Texas 75006, United States

Dallas, Texas 75251, United States

Houston, Texas 77074, United States

San Antonio, Texas 78224, United States

Magna, Utah 84044, United States

Salt Lake City, Utah 84107, United States

Richmond, Virginia 23249, United States

Gig Harbor, Washington 98335, United States

Menomonee Falls, Wisconsin 53051, United States

Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: April 2007
Last updated: June 9, 2011

Page last updated: August 23, 2015

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