NCT02072161

Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (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 and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Detailed description

Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ETC-1002	ETC-1002 capsules, taken once daily oral
DRUG	Placebo	Placebo capsules, taken once daily oral
DRUG	Statin Therapy	Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-02-26
• Last updated: 2019-03-29

Locations

40 sites across 1 country: United States