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

  Show 69 Study Locations
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 18, 2014