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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-04

Study Completion Date

2013-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ETC-1002

ETC-1002 treatment, once daily oral

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

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

Placebo

Placebo treatment, once daily oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily for 8 weeks

Interventions

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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

Intervention Type DRUG

Placebo

Placebo once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
* For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides \<350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
* For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG \<400 mg/dL