- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716595
A Phase III Long Term Study of K-877 Extended Release Tablet
August 8, 2022 updated by: Kowa Company, Ltd.
A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-
To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day.
If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fukuoka, Japan
- Saiseikai Futsukaichi Hospital
-
Gunma, Japan
- National Hospital Organization Takasaki General Medical Center
-
Hokkaido, Japan
- Hasegawa Medicine Clinic
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Hokkaido, Japan
- Japan Community Health care Organization Hokkaido Hospital
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Ibaraki, Japan
- Minami Akatsuka Clinic
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Kanagawa, Japan
- Saiseikai Yokohamashi Nanbu Hospital
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Osaka, Japan
- Kinugawa Cardiology Clinic
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Osaka, Japan
- Kyosokai Amc Nishi-Umeda Clinic
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Osaka, Japan
- Medical corporation Tani clinic
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Osaka, Japan
- Shiraiwa Medical Clinic
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Saitama, Japan
- Cosmos medical corporation Aozora total clinic
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Tokyo, Japan
- Akasaka Chuou Clinic
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Tokyo, Japan
- Medical Corporation Chiseikai Tokyo Center Clinic
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Tokyo, Japan
- Shimokitazawa Tomo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with dyslipidemia had to be age 20 years or older at written informed consent
- Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
- Patients with the fasting serum TG >= 150 mg/dL twice consecutively at Screening
Exclusion Criteria:
- Patients with a fasting serum TG > 1000 mg/dL at Screening
- Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- Patients with uncontrolled thyroid disease
- Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
- Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
- Patients with an AST or ALT three times the upper limit at Screening
- Patients with an CK five times the upper limit at Screening
- Patients with cirrhosis or those with biliary obstruction
- Patients with acute myocardial infarction within 3 months before obtaining informed consent
- Patients with heart failure class III or higher according to NYHA cardiac function classification
- Patients with malignant tumor or those who are judged to have a high risk of recurrence
- Patients with a history of serious drug allergies (anaphylactic shock, etc.)
- Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
- Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
- Patients who have received K-877 (pemafibrate)
- Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
- Patients who have been determined inappropriate by the investigator, etc
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: morning administration
K-877 ER 0.2 mg/day morning administration (once daily)
|
K-877 ER 0.2 mg tablet
Other Names:
|
Experimental: evening administration
K-877 ER 0.2 mg/day evening administration (once daily)
|
K-877 ER 0.2 mg tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Final evaluation (Week 52 or at discontinuation) and immediately before it
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
June 13, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
January 15, 2021
First Submitted That Met QC Criteria
January 15, 2021
First Posted (Actual)
January 20, 2021
Study Record Updates
Last Update Posted (Actual)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-877-ER-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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