Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01751984
First received: December 14, 2012
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
 Drug: ETC-1002 or placebo
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Percent change from baseline in LDL-C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in other lipids and cardio-metabolic risk factors [ Time Frame: 2, 4, 6 and 8 weeks ] [ Designated as safety issue: No ]
  • Percent achieving LDL-C goal [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with muscle related adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: October 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002 Drug: ETC-1002 or placebo
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 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • A history of documented statin intolerance to 2 or more statins that occurred 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 130-220 mg/dL and fasting TG <400 mg/dL

Key Exclusion Criteria:

  • Acute significant cardiovascular disease
  • Poorly controlled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01751984     History of Changes
Other Study ID Numbers: 1002-006
Study First Received: December 14, 2012
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013