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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779453
First Posted: January 30, 2013
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esperion Therapeutics
  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 Drug: Atorvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]
  • Peak plasma concentration (Cmax) of atorvastatin and its active metabolites [ Time Frame: 4 and 8 weeks ]
  • Number of subjects with adverse events, clinical lab abnormalities and other safety findings [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: 2, 4, 6 and 8 weeks ]
  • Percent change in other lipids and cardio-metabolic risk factors [ Time Frame: 2, 4, 6 and 8 weeks ]

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 ]

Enrollment: 58
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002
ETC-1002 treatment group, oral once daily
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
Drug: Atorvastatin
Atorvastatin 10mg once daily for 8 weeks
Placebo Comparator: Placebo
Placebo treatment group, oral once daily
Drug: Placebo
Placebo once daily for 8 weeks
Drug: Atorvastatin
Atorvastatin 10mg once daily for 8 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • For subjects on current daily statin therapy - LDL-C 100-220 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 ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion Criteria:

  • Acute significant cardiovascular disease
  • Uncontrolled hypertension
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779453


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

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01779453     History of Changes
Other Study ID Numbers: 1002-007
First Submitted: December 14, 2012
First Posted: January 30, 2013
Last Update Posted: September 11, 2015
Last Verified: August 2015

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

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


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