Status:
COMPLETED
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).
Eligibility Criteria
Inclusion
- Able to provide written informed consent before any study-specific evaluation is performed
- 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
- Able to meet all inclusion criteria outlined in clinical study protocol
Exclusion
- Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study
- Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
- Meet any other exclusion criteria outlined in clinical study protocol
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04447820
Start Date
June 10 2020
End Date
December 3 2020
Last Update
December 22 2023
Active Locations (12)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
Progressive Medical Research
Port Orange, Florida, United States, 32127
4
Columbus Regional Health
Columbus, Georgia, United States, 31904