Back to resultsA Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ETC-1002
Placebo
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Atorvastatin, Drug-drug interaction, Combination therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ETC-1002
Placebo
Arm Description
ETC-1002 treatment group, oral once daily
Placebo treatment group, oral once daily
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Secondary Outcome Measures
Percent change in LDL-C
Percent change in other lipids and cardio-metabolic risk factors
Full Information
NCT ID
NCT01779453
First Posted
December 14, 2012
Last Updated
March 26, 2019
Sponsor
Esperion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01779453
Brief Title
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Atorvastatin, Drug-drug interaction, Combination therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ETC-1002
Arm Type
Experimental
Arm Description
ETC-1002 treatment group, oral once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment group, oral once daily
Intervention Type
Drug
Intervention Name(s)
ETC-1002
Intervention Description
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 10mg once daily for 8 weeks
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Time Frame
4 and 8 weeks
Title
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Time Frame
4 and 8 weeks
Title
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percent change in LDL-C
Time Frame
2, 4, 6 and 8 weeks
Title
Percent change in other lipids and cardio-metabolic risk factors
Time Frame
2, 4, 6 and 8 weeks
Other Pre-specified Outcome Measures:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Rosenberg, MD
Organizational Affiliation
Esperion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
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