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

This study is currently recruiting participants.
Verified November 2013 by Esperion Therapeutics
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01941836
First received: September 6, 2013
Last updated: November 14, 2013
Last verified: November 2013

September 6, 2013
November 14, 2013
September 2013
October 2014   (final data collection date for primary outcome measure)
Percent change in calculated low density lipoprotein-cholesterol (LDL-C) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01941836 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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 ]
Same as current
 
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
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

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.

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.

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
    Patients receive ETC-1002
  • Drug: Ezetimibe
    Patients receive ezetimibe
    Other Name: Zetia
  • Experimental: ETC-1002 120 mg/day
    Orally, once daily in morning as capsules
    Intervention: Drug: ETC-1002
  • Experimental: ETC-1002 180 mg/day
    Orally, once daily in morning as capsules
    Intervention: Drug: ETC-1002
  • Active Comparator: ezetimibe 10mg/day
    Orally, once daily in morning as capsules
    Intervention: Drug: Ezetimibe
  • Experimental: ETC-1002 120 mg/day + ezetimibe 10mg/day
    Orally, once daily in morning
    Interventions:
    • Drug: ETC-1002
    • Drug: Ezetimibe
  • Experimental: ETC-1002 180 mg/day + ezetimibe 10mg/day
    Orally, once daily in morning
    Interventions:
    • Drug: ETC-1002
    • Drug: Ezetimibe

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
322
December 2014
October 2014   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Statin intolerant and statin tolerant
  • Fasting LDL-C between 100 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
Both
18 Years to 80 Years
No
Contact: Jeffrey C Hanselman, MS jhanselman@esperion.com
Contact: Janice R Margulies, MS jmargulies@esperion.com
United States
 
NCT01941836
1002-008
No
Esperion Therapeutics
Esperion Therapeutics
Medpace, Inc.
Study Director: Noah L Rosenberg, MD Esperion Therapeutics
Esperion Therapeutics
November 2013

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