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 |
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.
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
sites
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