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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01779453

Run by

Esperion Therapeutics, Inc.

People needed

58

Starts

2012-12-01

Expected to finish

2013-08-01

Last updated by the study team

2019-03-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
• For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

You may not qualify if…

• Acute significant cardiovascular disease
• Uncontrolled hypertension

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.