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A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides

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ClinicalTrials.gov Identifier: NCT01262638
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 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 Either Normal or Elevated Triglycerides.
Study Start Date : December 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ETC-1002 120 mg (Group 1)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: ETC-1002 80 mg (Group 2)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: ETC-1002 40 mg (Group 3)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: Placebo (Group 4)
Subjects with hypercholesterolemia and normal triglycerides
Drug: Placebo
Placebo daily for 12 weeks
Experimental: ETC-1002 120 mg (Group 5)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: ETC-1002 80 mg (Group 6)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: ETC-1002 40 mg (Group 7)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks
Experimental: Placebo (Group 8)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: Placebo
Placebo daily for 12 weeks



Primary Outcome Measures :
  1. To assess the LDL-C lowering efficacy of ETC-1002 versus placebo [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To assess the efficacy of ETC-1002 to modulate TG and other lipid and cardio-metabolic biomarkers [ Time Frame: 12 weeks ]
  2. To assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters [ Time Frame: 12 weeks ]


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

Major Inclusion Criteria:

  • Provision of written informed consent prior to any study-specific procedure
  • Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
  • Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
  • BMI between 18 and 35 mg/kg2

Major Exclusion Criteria:

  • Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
  • Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)

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): NCT01262638


Locations
United States, Arizona
Chandler, Arizona, United States, 85225
United States, California
Greenbrae, California, United States, 94904
Santa Rosa, California, United States, 95405
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Illinois
Chicago, Illinois, United States, 60654
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Michigan
Kalamazoo, Michigan, United States, 49007
United States, North Carolina
Raleigh, North Carolina, United States, 27609
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Esperion Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01262638     History of Changes
Other Study ID Numbers: ETC-1002-003
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: November 2011

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