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

March 26, 2019 updated by: Esperion Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Virginia
      • Richmond, Virginia, United States, 23294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ETC-1002
ETC-1002 treatment group, oral once daily
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
Drug: Atorvastatin
Atorvastatin 10mg once daily for 8 weeks
PLACEBO_COMPARATOR: Placebo
Placebo treatment group, oral once daily
Drug: Placebo
Placebo once daily for 8 weeks
Drug: Atorvastatin
Atorvastatin 10mg once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Time Frame: 4 and 8 weeks
4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Time Frame: 4 and 8 weeks
4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in LDL-C
Time Frame: 2, 4, 6 and 8 weeks
2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors
Time Frame: 2, 4, 6 and 8 weeks
2, 4, 6 and 8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
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
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esperion Therapeutics, Inc.

Investigators

  • Study Director: Noah Rosenberg, MD, Esperion Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

January 28, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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