NCT00639158

Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 543 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

Conditions

• Dyslipidemias
• Coronary Heart Disease
• Combined (Atherogenic) Dyslipidemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-10-01
• First posted: 2008-03-20
• Last updated: 2011-06-13
• Results posted: 2009-11-05

Locations

118 sites across 1 country: United States