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)

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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