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

NCT00300430 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	1911
Start date	2006-09

Conditions

• Dyslipidemia
• Coronary Heart Disease
• Mixed Dyslipidemia

Interventions

• ABT-335 and rosuvastatin calcium
• ABT-335 and atorvastatin calcium
• ABT-335 and simvastatin

Primary outcomes

• Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study — Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

Countries

United States