Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
NCT ID: NCT04447820
Last Updated: 2023-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2020-06-10
2020-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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K-877-ER Dose A
K-877-ER dose A administered once daily
K-877-ER (Dose A)
Dose A Oral Administration
K-877-ER Dose B
K-877-ER dose B administered once daily
K-877-ER (Dose B)
Dose B Oral Administration
K-877-IR
K-877-IR administered twice daily.
K-877-IR
K-877-IR Oral Administration
Interventions
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K-877-ER (Dose A)
Dose A Oral Administration
K-877-ER (Dose B)
Dose B Oral Administration
K-877-IR
K-877-IR Oral Administration
Eligibility Criteria
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Inclusion Criteria
* At screening, have a mean fasting TG level of ≥180 mg/dL and \<550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and \<500 mg/dL
Exclusion Criteria
* Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
18 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Columbus Regional Health
Columbus, Georgia, United States
Prism Research
Saint Paul, Minnesota, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, United States
Medpace Clinical Pharmacology, LLC
Cincinnati, Ohio, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Summit Research Group, LLC
Munroe Falls, Ohio, United States
Health Concepts
Rapid City, South Dakota, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol: Ver: 1.0
Document Type: Study Protocol: Ver: 2.0
Document Type: Statistical Analysis Plan: Ver 1.0
Document Type: Statistical Analysis Plan: Ver 2.0
Other Identifiers
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K-877-ER-201
Identifier Type: -
Identifier Source: org_study_id