NCT01779453

A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ETC-1002	Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
DRUG	Placebo	Placebo once daily for 8 weeks
DRUG	Atorvastatin	Atorvastatin 10mg once daily for 8 weeks

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-01-30
• Last updated: 2019-03-29

Locations

3 sites across 1 country: United States