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Completed

NCT Number: NCT01779453

A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin 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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETC-1002

Drug

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

Drug

Placebo once daily for 8 weeks

atorvastatin

Drug

Atorvastatin 10mg once daily for 8 weeks

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites

    Time frame: 4 and 8 weeks

  2. Peak plasma concentration (Cmax) of atorvastatin and its active metabolites

    Time frame: 4 and 8 weeks

  3. Number of subjects with adverse events, clinical lab abnormalities and other safety findings

    Time frame: 8 weeks

Secondary outcomes

  1. Percent change in LDL-C

    Time frame: 2, 4, 6 and 8 weeks

  2. Percent change in other lipids and cardio-metabolic risk factors

    Time frame: 2, 4, 6 and 8 weeks

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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