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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Acute significant cardiovascular disease

• Uncontrolled hypertension