NCT01941836

Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Detailed description

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ETC-1002	Patients receive ETC-1002
DRUG	Ezetimibe	Patients receive ezetimibe

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2013-09-13
• Last updated: 2019-03-29

Locations

68 sites across 1 country: United States