NCT01751984

A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and a History of Statin Intolerance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ETC-1002	Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day
DRUG	Placebo	Placebo once daily for 8 weeks

Timeline

• Start date: 2012-10-04
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-12-18
• Last updated: 2022-04-04
• Results posted: 2022-04-04

Locations

5 sites across 1 country: United States