ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 5 for:    23770179 [PUBMED-IDS]

A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

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.
ClinicalTrials.gov Identifier: NCT02659397
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: ETC-1002 Drug: Atorvastatin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients
Study Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ETC-1002 + Atorvastatin
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Drug: ETC-1002
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Other Name: bempedoic acid

Drug: Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)

Placebo Comparator: Placebo + Atorvastatin
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Drug: Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)

Drug: Placebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites [ Time Frame: 2 weeks ]
    Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002

  2. 24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites [ Time Frame: 2 weeks ]
    Fold change in AUC from prior-to to following 2 week treatment with ETC-1002

  3. Percent change in LDL-cholesterol [ Time Frame: 4 weeks ]
    Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C


Secondary Outcome Measures :
  1. Percent change in hsCRP [ Time Frame: 4 weeks ]
    Percent change from baseline to following 4 week treatment with ETC-1002

  2. Percent change in total cholesterol [ Time Frame: 4 weeks ]
    Percent change from baseline to following 4 week treatment with ETC-1002

  3. Percent change in non-HDL-cholesterol [ Time Frame: 4 weeks ]
    Percent change from baseline to following 4 week treatment with ETC-1002

  4. Percent change in apolipoprotein B [ Time Frame: 4 weeks ]
    Percent change from baseline to following 4 week treatment with ETC-1002

  5. 24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite [ Time Frame: 2 weeks ]
    Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002



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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Taking daily stable statin doses for at least 4 weeks prior to screening visit.
  • LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
  • LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
  • Must be willing to discontinue other lipid-regulating therapies during the study

Exclusion Criteria:

  • History of acute significant cardiovascular disease.
  • Current clinically significant cardiovascular disease.
  • History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.

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): NCT02659397


Locations
United States, California
Anaheim, California, United States, 92801
Los Angeles, California, United States, 90057
Northridge, California, United States, 91324
United States, Florida
Clearwater, Florida, United States, 33765
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33126
Port Orange, Florida, United States, 32127
United States, Idaho
Boise, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60607
Springfield, Illinois, United States, 62711
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Texas
Carrollton, Texas, United States, 75006
United States, Utah
West Jordan, Utah, United States, 84088
United States, Virginia
Arlington, Virginia, United States, 22203
Lynchburg, Virginia, United States, 24501
Richmond, Virginia, United States, 23294
United States, Washington
Renton, Washington, United States, 98057
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Mary McGowan, MD Esperion Therapeutics

Publications:

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT02659397     History of Changes
Other Study ID Numbers: 1002-035
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Esperion Therapeutics:
LDL-cholesterol
Hypercholesterolemia
ETC-1002
Adenosine triphosphate citrate lyase
Atorvastatin

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
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