NCT00300456

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

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 657 (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) + simvastatin combination therapy with ABT-335 and simvastatin 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	Simvastatin	daily, 12 weeks, see Arm Description for dosage information
DRUG	Placebo	Daily, 12 weeks, see Arm Description for placebo information

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-03-01
• First posted: 2006-03-09
• Last updated: 2009-06-03
• Results posted: 2009-03-25

Locations

1 site across 1 country: United States