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A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance

NCT01751984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-04-04

Study results available
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Summary

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Conditions

Interventions

DRUG

ETC-1002

Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day

DRUG

Placebo

Placebo once daily for 8 weeks

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-04
Primary Completion
2013-05-01
Completion
2013-05-01

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751984 on ClinicalTrials.gov