Official Title: “A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia”

The primary purpose of this study is to test the effect and safety of using an investigational drug regimen containing three medications; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin and once daily ezetimibe to study the effects on patients with abnormal lipid (fat) levels in the blood.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: ABT-335
  • 135 mg capsule, daily, 12 weeks
• Drug: placebo
  • placebo capsule, daily, 12 weeks
• Drug: atorvastatin
  • 40 mg, tablet, daily, 12 weeks
• Drug: ezetimibe
  • 10 mg capsule, daily, 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • ABT-335, atorvastatin, ezetimibe
• Placebo Comparator: B
  • placebo, atorvastatin, ezetimibe

Primary Measures

• Identify rate of change by measuring baseline levels of triglycerides at various study intervals
  • Time Frame: 12 weeks
    Safety Issue?: No
• Identify rate of change by measuring baseline levels of HDL-C at various study intervals
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients with mixed dyslipidemia.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639158

Study ID Number: M10-275

ClinicalTrials.gov Identifier: NCT00639158

Health Authority: United States: Food and Drug Administration