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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:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01751984
First received: December 14, 2012
Last updated: August 19, 2013
Last verified: August 2013

December 14, 2012
August 19, 2013
October 2012
May 2013   (final data collection date for primary outcome measure)
Percent change from baseline in LDL-C [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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
  • Drug: Placebo
  • Experimental: ETC-1002
    Intervention: Drug: ETC-1002 or placebo
  • Placebo Comparator: Placebo
    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
54
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01751984
1002-006
No
Esperion Therapeutics
Esperion Therapeutics
Not Provided
Study Director: Noah Rosenberg, MD Esperion Therapeutics, Inc.
Esperion Therapeutics
August 2013

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