Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT02072161
First received: February 24, 2014
Last updated: August 27, 2015
Last verified: August 2015
  Purpose
The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Condition Intervention Phase
Hypercholesterolemia
Drug: ETC-1002
Drug: Placebo
Drug: Statin Therapy
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 Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

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

Secondary Outcome Measures:
  • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in apolipoprotein B (ApoB) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in total cholesterol (TC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in triglycerides (TG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change in lipoprotein particle number [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety using adverse event reports; clinical laboratory results [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Safety using adverse event reports; vital signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: March 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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
ETC-1002 capsules, taken once daily oral
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Experimental: ETC-1002 180 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
ETC-1002 capsules, taken once daily oral
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Placebo Comparator: Placebo
Orally, once daily in morning
Drug: Placebo
Placebo capsules, taken once daily oral
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.

Detailed Description:
Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
  • Fasting mean TG level ≤400 mg/dL
  • Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

Exclusion Criteria:

  • Clinically significant cardiovascular disease within 12 months of screening
  • Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
  • Type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
  • History of chronic musculoskeletal symptoms such as fibromyalgia
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal conditions or procedures or surgeries
  • Hematologic or coagulation disorders or low hemoglobin levels
  • HIV or AIDS
  • History of malignancy
  • History of drug or alcohol abuse within 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: NCT02072161

  Show 40 Study Locations
Sponsors and Collaborators
Esperion Therapeutics
Medpace, Inc.
Investigators
Study Director: Diane E MacDougall Esperion Therapeutics
  More Information

Publications:

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT02072161     History of Changes
Other Study ID Numbers: 1002-009 
Study First Received: February 24, 2014
Last Updated: August 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Esperion Therapeutics:
Statin
LDL
Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 26, 2016