NCT00300430

Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,911 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Conditions

• Dyslipidemia
• Coronary Heart Disease
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	ABT-335 and rosuvastatin calcium	ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
DRUG	ABT-335 and atorvastatin calcium	ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
DRUG	ABT-335 and simvastatin	ABT-335 135 mg plus simvastatin daily, 52 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-03-01
• First posted: 2006-03-09
• Last updated: 2009-07-23
• Results posted: 2009-07-23

Locations

1 site across 1 country: United States