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A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

This study is currently recruiting participants.
Verified January 2013 by Esperion Therapeutics
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01779453
First received: December 14, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.


Condition Intervention Phase
Hypercholesterolemia
 Drug: ETC-1002
Drug: Placebo
 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 Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of atorvastatin and its active metabolites [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Number of subjects with adverse events, clinical lab abnormalities and other safety findings [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: 2, 4, 6 and 8 weeks ] [ Designated as safety issue: No ]
  • Percent change in other lipids and cardio-metabolic risk factors [ Time Frame: 2, 4, 6 and 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002 Drug: ETC-1002
Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • For subjects on current daily statin therapy - LDL-C 115-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
  • For subjects not on current daily statin therapy - LDL-C ≥ 140 mg/dL and ≤ 220 mg/dL

Exclusion Criteria:

  • Acute significant cardiovascular disease
  • Uncontrolled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779453

Contacts
Contact: Janice Margulies, MS 734.862.4853 jmargulies@esperion.com

Locations
United States, Indiana
Recruiting
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40213
United States, Virginia
Recruiting
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Noah Rosenberg, MD Esperion Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01779453     History of Changes
Other Study ID Numbers: 1002-007
Study First Received: December 14, 2012
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Esperion Therapeutics:
Atorvastatin
Drug-drug interaction
Combination therapy

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

ClinicalTrials.gov processed this record on June 17, 2013