Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01941836
First received: September 6, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.


Condition Intervention Phase
Hypercholesterolemia
Drug: ETC-1002
Drug: Ezetimibe
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 Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Percent change in calculated low density lipoprotein-cholesterol (LDL-C) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Safety using adverse event reports; vital signs [ Time Frame: up to 21 weeks including screening ] [ Designated as safety issue: Yes ]
  • Percent change in Apolipoprotein B (ApoB) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in high sensitivity C-reactive protein (hsCRP) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Safety using adverse event reports; clinical laboratory results [ Time Frame: up to 21 weeks including screening ] [ Designated as safety issue: Yes ]
  • Safety using adverse event reports; rates of muscle-related adverse [ Time Frame: up to 21 weeks including screening ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Pharmacokinetic plasma trough concentrations of ETC-1002 and its metabolite ESP15228 [ Time Frame: Week 2, Week 4, Week 8 and Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 322
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002 120 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
Patients receive ETC-1002
Experimental: ETC-1002 180 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
Patients receive ETC-1002
Active Comparator: ezetimibe 10mg/day
Orally, once daily in morning as capsules
Drug: Ezetimibe
Patients receive ezetimibe
Other Name: Zetia
Experimental: ETC-1002 120 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
Drug: ETC-1002
Patients receive ETC-1002
Drug: Ezetimibe
Patients receive ezetimibe
Other Name: Zetia
Experimental: ETC-1002 180 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
Drug: ETC-1002
Patients receive ETC-1002
Drug: Ezetimibe
Patients receive ezetimibe
Other Name: Zetia

Detailed Description:

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

  Eligibility

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

Key Inclusion Criteria:

  • Statin intolerant and statin tolerant
  • Fasting LDL-C between 130 mg/dL and 220 mg/dL
  • Fasting triglyceride less than or equal to 400 mg/dL
  • Body mass index (BMI) between 18 and 45 kg/m2

Key Exclusion Criteria:

  • History or current clinically significant cardiovascular disease
  • History or current type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 3 months of screening
  • History of joint symptoms difficult to differentiate from myalgia
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal (GI) conditions or prior GI procedures
  • HIV or AIDS
  • History or malignancy
  • History or drug or alcohol abuse within last 2 years
  • Use of experimental or investigational drugs within 30 days of screening
  • Use of ETC-1002 in a previous clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941836

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Chandler, Arizona, United States, 85224
United States, California
Beverly Hills, California, United States, 90211
Chino, California, United States, 91710
Lincoln, California, United States, 95821
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90059
Newport Beach, California, United States, 92663
Thousand Oaks, California, United States, 91360
Vista, California, United States, 92083
United States, Colorado
Denver, Colorado, United States, 80220
United States, Connecticut
Hartford, Connecticut, United States, 06102
United States, Florida
Atlantis, Florida, United States, 33462
Brandon, Florida, United States, 33511
Hialeah, Florida, United States, 33012
Jacksonville, Florida, United States, 32223
Oviedo, Florida, United States, 32765
Ponte Vedra, Florida, United States, 32081
Port Orange, Florida, United States, 32127
St. Petersburg, Florida, United States, 33756
West Palm Beach, Florida, United States, 33409
United States, Georgia
Decatur, Georgia, United States, 30033
Marietta, Georgia, United States, 30066
United States, Idaho
Meridian, Idaho, United States, 83646
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Kansas
Kansas City, Kansas, United States, 66214
United States, Maine
Auburn, Maine, United States, 04210
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Clifton, New Jersey, United States, 07012
United States, New Mexico
Albequerque, New Mexico, United States, 87106
United States, New York
New Windsor, New York, United States, 12553
Rochester, New York, United States, 14609
Williamsville, New York, United States, 14221
United States, North Carolina
Greensboro, North Carolina, United States, 27408
Raleigh, North Carolina, United States, 27609
Salisbury, North Carolina, United States, 28144
Wilmington, North Carolina, United States, 28401
United States, Ohio
Beachwood, Ohio, United States, 26900
Cincinnati, Ohio, United States, 45227
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43213
Franklin, Ohio, United States, 45005
Lyndhurst, Ohio, United States, 44124
Marion, Ohio, United States, 43302
Willoughby Hills, Ohio, United States, 44094
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Eugene, Oregon, United States, 97404
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin, Texas, United States, 78731
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75216
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77074
Houston, Texas, United States, 77030
Houston, Texas, United States, 77072
Round Rock, Texas, United States, 78681
United States, Utah
Orem, Utah, United States, 84058
Salt Lake City, Utah, United States, 84124
United States, Virginia
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
United States, Washington
Olympia, Washington, United States, 98502
Renton, Washington, United States, 98057
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Esperion Therapeutics
Medpace, Inc.
Investigators
Study Director: Diane E MacDougall, MS Esperion Therapeutics
  More Information

Publications:

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01941836     History of Changes
Other Study ID Numbers: 1002-008
Study First Received: September 6, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Esperion Therapeutics:
Statin intolerant
Statin tolerant
LDL
Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014