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 (FIRST)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia

Treatments: Other: Atorvastatin; Drug: ABT-335; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616772

M10-158

Details and patient eligibility

About

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.

Enrollment: 682 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mixed dyslipidemia
• Qualifying cIMT thickness

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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682 participants in 2 patient groups, including a placebo group

ABT-335 + Atorvastatin

Experimental group

Description:

ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.

Treatment:

Drug: ABT-335

Other: Atorvastatin

Placebo + Atorvastatin

Placebo Comparator group

Description:

Placebo and atorvastatin (up to 40 mg) once daily for 2 years.

Treatment:

Drug: Placebo

Other: Atorvastatin