Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Disease, Coronary Heart Disease, Dyslipidemia

In brief

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Key facts

Study ID

NCT00616772

Run by

AbbVie (prior sponsor, Abbott)

People needed

682

Starts

2008-02-01

Expected to finish

2012-09-01

Last updated by the study team

2018-07-02

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with mixed dyslipidemia
• Qualifying cIMT thickness

You may not qualify if…

• Patients with certain chronic or unstable medical conditions.
• Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
• Pregnant or lactating women or women intending to become pregnant
• Patients with diabetes mellitus that is poorly controlled

Where it is running

• Site Reference ID/Investigator# 7089 — Gilbert, Arizona, United States
• Site Reference ID/Investigator# 7097 — Mesa, Arizona, United States
• Site Reference ID/Investigator# 26394 — Phoenix, Arizona, United States
• Site Reference ID/Investigator# 6848 — Scottsdale, Arizona, United States
• Site Reference ID/Investigator# 7059 — Tempe, Arizona, United States
• Site Reference ID/Investigator# 7094 — Tempe, Arizona, United States
• Site Reference ID/Investigator# 7098 — Tempe, Arizona, United States
• Site Reference ID/Investigator# 25082 — Anaheim, California, United States
• Site Reference ID/Investigator# 21347 — Corona, California, United States
• Site Reference ID/Investigator# 21483 — Garden Grove, California, United States
• Site Reference ID/Investigator# 21351 — Huntington Beach, California, United States
• Site Reference ID/Investigator# 21346 — Laguna Hills, California, United States
• Site Reference ID/Investigator# 21341 — Long Beach, California, United States
• Site Reference ID/Investigator# 21342 — Norwalk, California, United States
• Site Reference ID/Investigator# 21321 — Santa Ana, California, United States
• Site Reference ID/Investigator# 26242 — Tustin, California, United States
• Site Reference ID/Investigator# 15283 — Arvada, Colorado, United States
• Site Reference ID/Investigator# 7085 — Aurora, Colorado, United States
• Site Reference ID/Investigator# 6749 — Denver, Colorado, United States
• Site Reference ID/Investigator# 7077 — Denver, Colorado, United States
• Site Reference ID/Investigator# 7092 — Golden, Colorado, United States
• Site Reference ID/Investigator# 7722 — Littleton, Colorado, United States
• Site Reference ID/Investigator# 7721 — Littleton, Colorado, United States
• Site Reference ID/Investigator# 11925 — Aventura, Florida, United States
• Site Reference ID/Investigator# 6747 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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