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NCT03001817 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
A Phase 3 study of Severe Hypertriglyceridemia, sponsored by Kowa Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 551
- Enrollment target
- 20
- Study locations
NCT03001817: Completed Phase 3 study of Severe Hypertriglyceridemia, sponsored by Kowa Research Institute.
NCT03001817 is a Phase 3 study of Severe Hypertriglyceridemia that has completed, run by Kowa Research Institute. The registered enrollment target is 551 participants, above the 356-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03001817, a Phase 3 study of Severe Hypertriglyceridemia, has completed, sponsored by Kowa Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 551 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and \<2000 mg/dL and normal renal function.
Conditions Studied
Interventions
- DRUG Fenofibrate
- DRUG K-877
- DRUG Placebo (for K-877)
- DRUG Placebo (for Fenofibrate)
Study Locations (20)
Alabama
- Central Research Associates, Inc. - Birmingham
- Central Alabama Research - Birmingham
- Cahaba Research, Inc. - Birmingham
- Boyett Health Services Inc - Hamilton
- Longwood Research - Saadat Ansari, MD, LLC - Huntsville
- Terence T. Hart, MD - Tuscumbia
California
- Advanced Research Center - Anaheim
- Torrance Clinical Research Institute Inc. - Lomita
- Downtown L.A. Research Center, Inc. - Los Angeles
- Catalina Research Institute, LLC - Montclair
- Lucita M. Cruz, MD., Inc. - Norwalk
Arizona
- Arrowhead Health Centers - Glendale
- Phoenix Medical Research Institute, LLC - Peoria
- Elite Clinical Studies - Phoenix
- Clinical Research Institute of Arizona, LLC - Surprise
Arkansas
- iResearch - Little Rock - Little Rock
- Lynn Institute of the Ozarks - Little Rock
Florida
- Atlantic Clinical Research Collaborative - Boynton Beach
- ALL Medical Research, LLC - Cooper City
Colorado
- Creekside Endocrine Associates, PC - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2016-11-28 |
| Est. Completion | 2019-06-24 |
| Phase | Phase 3 |
What the finished NCT03001817 record still lists
NCT03001817 is an interventional study that assigns participants to a tested intervention. The registered 551 participants enrollment target is mid-sized for trials with a published cap, above the 356-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Severe Hypertriglyceridemia appearing as the primary indexed condition, and to 4 interventions - of which Fenofibrate is the first listed.
NCT03001817 names 20 study sites across 6 states, led by Alabama, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03001817 about?
NCT03001817 is a clinical study titled "Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function". The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and \<2000 mg/dL and normal renal function.
What is the current status of trial NCT03001817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2016-11-28. Estimated completion is 2019-06-24.
What conditions does trial NCT03001817 study?
This clinical trial studies the following conditions: Severe Hypertriglyceridemia.
What interventions are being tested in trial NCT03001817?
The interventions under investigation include: Fenofibrate (DRUG), K-877 (DRUG), Placebo (for K-877) (DRUG), Placebo (for Fenofibrate) (DRUG).
Who is sponsoring clinical trial NCT03001817?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03001817 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Severe Hypertriglyceridemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03001817's enrollment target sits among peer trials
551 2nd of 8 the highest of 8 other Severe Hypertriglyceridemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Severe Hypertriglyceridemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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