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

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ClinicalTrials.gov Identifier: NCT01751984
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in subjects with hypercholesterolemia and a history of statin intolerance.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: ETC-1002 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and a History of Statin Intolerance
Study Start Date : October 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ETC-1002
ETC-1002 treatment, once daily oral
Drug: ETC-1002
Weeks 1-2, 60 mg/day; Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day
Placebo Comparator: Placebo
Placebo treatment, once daily oral
Drug: Placebo
Placebo once daily for 8 weeks


Outcome Measures

Primary Outcome Measures :
  1. Percent change from baseline in LDL-C [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline in other lipids and cardio-metabolic risk factors [ Time Frame: 2, 4, 6 and 8 weeks ]
  2. Percent achieving LDL-C goal [ Time Frame: 8 weeks ]
  3. Number of subjects with adverse events [ Time Frame: 8 weeks ]
  4. Number of subjects with muscle related adverse events [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Acute significant cardiovascular disease
  • Poorly controlled hypertension
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751984


Locations
United States, Connecticut
Hartford, Connecticut, United States, 06102
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, North Carolina
Raleigh, North Carolina, United States, 27609
Wilmington, North Carolina, United States, 28401
United States, Tennessee
Knoxville, Tennessee, United States, 37912
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Noah Rosenberg, MD Esperion Therapeutics, Inc.
More Information

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01751984     History of Changes
Other Study ID Numbers: 1002-006
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: August 2015

Keywords provided by Esperion Therapeutics:
lipid-lowering drugs
statin intolerance

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents