NCT00300482

Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Rosuvastatin Calcium Combination Therapy to Fenofibric Acid and Rosuvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,445 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.

Conditions

• Dyslipidemia
• Coronary Heart Disease
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	ABT-335	135 mg, daily, 12 weeks
DRUG	Rosuvastatin Calcium	Daily, 12 weeks, see Arm Description for dosage information
DRUG	Placebo	Daily, 12 weeks, see Arm Description for information regarding placebo type

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-12-01
• First posted: 2006-03-09
• Last updated: 2009-06-10
• Results posted: 2009-03-25

Locations

1 site across 1 country: United States