A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779453
• Other study ID #: 1002-007
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2019
• Source: Esperion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,

• For subjects not on current daily statin therapy - LDL-C = 110 mg/dL and = 220 mg/dL

Exclusion Criteria:

• Acute significant cardiovascular disease

• Uncontrolled hypertension

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ETC-1002
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
Placebo once daily for 8 weeks
• Atorvastatin
Atorvastatin 10mg once daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite		4 and 8 weeks
Primary	Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites		4 and 8 weeks
Primary	Peak plasma concentration (Cmax) of atorvastatin and its active metabolites		4 and 8 weeks
Primary	Number of subjects with adverse events, clinical lab abnormalities and other safety findings		8 weeks
Secondary	Percent change in LDL-C		2, 4, 6 and 8 weeks
Secondary	Percent change in other lipids and cardio-metabolic risk factors		2, 4, 6 and 8 weeks