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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT02659397

Run by

Esperion Therapeutics, Inc.

People needed

68

Starts

2015-12-01

Expected to finish

2016-07-01

Last updated by the study team

2019-03-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Los Angeles, California, United States
• Study site — Northridge, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Berlin, New Jersey, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Carrollton, Texas, United States
• Study site — West Jordan, Utah, United States
• Study site — Arlington, Virginia, United States
• Study site — Lynchburg, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Renton, Washington, United States

Full record on ClinicalTrials.gov

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