Back to resultsA Phase III Long Term Study of K-877 Extended Release Tablet
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
K-877 ER 0.2 mg/day morning administration (once daily)
K-877 ER 0.2 mg/day evening administration (once daily)
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility Criteria
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
Sites / Locations
- Saiseikai Futsukaichi Hospital
- National Hospital Organization Takasaki General Medical Center
- Hasegawa Medicine Clinic
- Japan Community Health care Organization Hokkaido Hospital
- Minami Akatsuka Clinic
- Saiseikai Yokohamashi Nanbu Hospital
- Kinugawa Cardiology Clinic
- Kyosokai AMC NISHI-UMEDA Clinic
- Medical corporation Tani clinic
- Shiraiwa medical clinic
- Cosmos medical corporation Aozora total clinic
- Akasaka Chuou Clinic
- Medical Corporation Chiseikai Tokyo Center Clinic
- Shimokitazawa Tomo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
morning administration
evening administration
Arm Description
K-877 ER 0.2 mg/day morning administration (once daily)
K-877 ER 0.2 mg/day evening administration (once daily)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04716595
Brief Title
A Phase III Long Term Study of K-877 Extended Release Tablet
Official Title
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-
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
morning administration
Arm Type
Experimental
Arm Description
K-877 ER 0.2 mg/day morning administration (once daily)
Arm Title
evening administration
Arm Type
Experimental
Arm Description
K-877 ER 0.2 mg/day evening administration (once daily)
Intervention Type
Drug
Intervention Name(s)
K-877 ER 0.2 mg/day morning administration (once daily)
Other Intervention Name(s)
Pemafibrate ER 0.2 mg/day morning administration (once daily)
Intervention Description
K-877 ER 0.2 mg tablet
Intervention Type
Drug
Intervention Name(s)
K-877 ER 0.2 mg/day evening administration (once daily)
Other Intervention Name(s)
Pemafibrate ER 0.2 mg/day evening administration (once daily)
Intervention Description
K-877 ER 0.2 mg tablet
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Saiseikai Futsukaichi Hospital
City
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Gunma
Country
Japan
Facility Name
Hasegawa Medicine Clinic
City
Hokkaido
Country
Japan
Facility Name
Japan Community Health care Organization Hokkaido Hospital
City
Hokkaido
Country
Japan
Facility Name
Minami Akatsuka Clinic
City
Ibaraki
Country
Japan
Facility Name
Saiseikai Yokohamashi Nanbu Hospital
City
Kanagawa
Country
Japan
Facility Name
Kinugawa Cardiology Clinic
City
Osaka
Country
Japan
Facility Name
Kyosokai AMC NISHI-UMEDA Clinic
City
Osaka
Country
Japan
Facility Name
Medical corporation Tani clinic
City
Osaka
Country
Japan
Facility Name
Shiraiwa medical clinic
City
Osaka
Country
Japan
Facility Name
Cosmos medical corporation Aozora total clinic
City
Saitama
Country
Japan
Facility Name
Akasaka Chuou Clinic
City
Tokyo
Country
Japan
Facility Name
Medical Corporation Chiseikai Tokyo Center Clinic
City
Tokyo
Country
Japan
Facility Name
Shimokitazawa Tomo Clinic
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase III Long Term Study of K-877 Extended Release Tablet
We'll reach out to this number within 24 hrs