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



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 70
Updated:3/31/2019
Start Date:December 2015
End Date:July 2016

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A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients

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.


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.
We found this trial at
19
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