A Phase 2 interventional study of ETC-1002 and Placebo in Hypercholesterolemia, sponsored by Esperion Therapeutics, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Esperion Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.
This study's enrollment of 58 is below the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Esperion Therapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
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ETC-1002 treatment group, oral once daily
Drug: ETC-1002 · Drug: Atorvastatin
Placebo treatment group, oral once daily
Drug: Placebo · Drug: Atorvastatin
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Placebo once daily for 8 weeks
Atorvastatin 10mg once daily for 8 weeks
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Time frame: 8 weeks
Percent change in LDL-C
Time frame: 2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors
Time frame: 2, 4, 6 and 8 weeks
Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite
Time frame: 4 and 8 weeks
The record gives a start of Dec 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bempedoic acid · Atorvastatin