Clinical trial NCT00465088: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Mixed Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 199
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Percent Change in HDL-C From Baseline to Week 8
timeFrame: From baseline to Week 8
measure: Percent Change in Non-HDL-C From Baseline to Week 8
timeFrame: From baseline to Week 8
measure: Percent Change in Non-HDL-C From Baseline to Week 12
timeFrame: From baseline to Week 12
measure: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12
timeFrame: From baseline to Week 12
measure: Percent Change in Triglycerides From Baseline to Week 12
timeFrame: From baseline to Week 12
measure: Percent Change in LDL-C:HDL-C Ratio
timeFrame: From baseline to Week 12
measure: Percent Change in Total Cholesterol From Baseline to Week 12
timeFrame: From baseline to Week 12
measure: Percent Change in Total Cholesterol:HDL-C Ratio
timeFrame: From baseline to Week 12
measure: Percent Change in Lipoprotein A From Baseline to Week 12
timeFrame: From baseline to Week 12
measure: Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12
timeFrame: 12 weeks
measure: Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12
timeFrame: 12 weeks
measure: Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12
timeFrame: 12 weeks
measure: Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Brooksville
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Calhoun
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Dunwoody
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Arkansas City
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Shawnee Mission
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Charlotte
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Canfield
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Protland
country: United States
state: Oregon
city: Chicora
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Magna
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Gig Harbor
country: United States
state: Washington
city: Menomonee Falls
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Abbott
name: Roopal Thakkar, MD
role: STUDY_DIRECTOR
References: