Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

Completed · Phase 3

Conditions studied: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

In brief

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Key facts

Study ID

NCT00812955

Run by

AstraZeneca

People needed

474

Starts

2008-11-01

Expected to finish

2009-06-01

Last updated by the study team

2012-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with hypercholesterolemia and hypertriglyceridemia.
• Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):
• Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
• Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

You may not qualify if…

• Participants with certain chronic or unstable medical conditions.
• Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
• Pregnant or lactating women, or women intending to become pregnant.
• Participants with diabetes mellitus that is poorly controlled.
• Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Where it is running

• Site Reference ID/Investigator# 12634 — Columbiana, Alabama, United States
• Site Reference ID/Investigator# 12559 — Huntsville, Alabama, United States
• Site Reference ID/Investigator# 12499 — Ozark, Alabama, United States
• Site Reference ID/Investigator# 12673 — Chandler, Arizona, United States
• Site Reference ID/Investigator# 17282 — Scottsdale, Arizona, United States
• Site Reference ID/Investigator# 12657 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 12489 — Anaheim, California, United States
• Site Reference ID/Investigator# 12495 — Carmichael, California, United States
• Site Reference ID/Investigator# 12467 — Chula Vista, California, United States
• Site Reference ID/Investigator# 12498 — Long Beach, California, United States
• Site Reference ID/Investigator# 12602 — Los Angeles, California, United States
• Site Reference ID/Investigator# 12510 — Norwalk, California, United States
• Site Reference ID/Investigator# 12550 — Palm Desert, California, United States
• Site Reference ID/Investigator# 16503 — Roseville, California, United States
• Site Reference ID/Investigator# 12678 — Sacramento, California, United States
• Site Reference ID/Investigator# 14241 — Sacramento, California, United States
• Site Reference ID/Investigator# 12473 — San Diego, California, United States
• Site Reference ID/Investigator# 12497 — Walnut Creek, California, United States
• Site Reference ID/Investigator# 12680 — West Hills, California, United States
• Site Reference ID/Investigator# 12461 — Colorado Springs, Colorado, United States
• Site Reference ID/Investigator# 12600 — Colorado Springs, Colorado, United States
• Site Reference ID/Investigator# 12679 — Waterbury, Connecticut, United States
• Site Reference ID/Investigator# 12598 — Clearwater, Florida, United States
• Site Reference ID/Investigator# 15542 — Coral Gables, Florida, United States
• Site Reference ID/Investigator# 12654 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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