A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.

• 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:

• Taking daily stable statin doses for at least 4 weeks prior to screening visit.

• LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,

• LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.

• Must be willing to discontinue other lipid-regulating therapies during the study

Exclusion Criteria:

• History of acute significant cardiovascular disease.

• Current clinically significant cardiovascular disease.

• History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.