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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751984
First Posted: December 18, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esperion Therapeutics
December 14, 2012
December 18, 2012
September 11, 2015
October 2012
May 2013   (Final data collection date for primary outcome measure)
Percent change from baseline in LDL-C [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01751984 on ClinicalTrials.gov Archive Site
  • Percent change from baseline in other lipids and cardio-metabolic risk factors [ Time Frame: 2, 4, 6 and 8 weeks ]
  • Percent achieving LDL-C goal [ Time Frame: 8 weeks ]
  • Number of subjects with adverse events [ Time Frame: 8 weeks ]
  • Number of subjects with muscle related adverse events [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of ETC-1002 in Subjects With Statin Intolerance
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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
  • Drug: Placebo
    Placebo once daily for 8 weeks
  • Experimental: ETC-1002
    ETC-1002 treatment, once daily oral
    Intervention: Drug: ETC-1002
  • Placebo Comparator: Placebo
    Placebo treatment, once daily oral
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01751984
1002-006
No
Not Provided
Not Provided
Esperion Therapeutics
Esperion Therapeutics
Not Provided
Study Director: Noah Rosenberg, MD Esperion Therapeutics, Inc.
Esperion Therapeutics
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP