Clinical trial NCT04716595: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Kowa Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 121
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients with dyslipidemia had to be age 20 years or older at written informed consent
2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
3. Patients with the fasting serum TG \>= 150 mg/dL twice consecutively at Screening

Exclusion Criteria:

1. Patients with a fasting serum TG \> 1000 mg/dL at Screening
2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
3. Patients with uncontrolled thyroid disease
4. Patients with type 1 diabetes and uncontrolled diabetes \[HbA1c(NGSP) \>= 10.0 % at Screening\]
5. Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg)
6. Patients with an AST or ALT three times the upper limit at Screening
7. Patients with an CK five times the upper limit at Screening
8. Patients with cirrhosis or those with biliary obstruction
9. Patients with acute myocardial infarction within 3 months before obtaining informed consent
10. Patients with heart failure class III or higher according to NYHA cardiac function classification
11. Patients with malignant tumor or those who are judged to have a high risk of recurrence
12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
13. 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
14. 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
15. Patients who have received K-877 (pemafibrate)
16. 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
17. Patients who have been determined inappropriate by the investigator, etc

Primary outcomes:
measure: 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
timeFrame: Final evaluation (Week 52 or at discontinuation) and immediately before it
Secondary outcomes:
measure: 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
timeFrame: Final evaluation (Week 52 or at discontinuation) and immediately before it
measure: 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
timeFrame: Final evaluation (Week 52 or at discontinuation) and immediately before it
measure: 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
timeFrame: Final evaluation (Week 52 or at discontinuation) and immediately before it
measure: 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
timeFrame: Final evaluation (Week 52 or at discontinuation) and immediately before it
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Saiseikai Futsukaichi Hospital
city: Gunma
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Hokkaido
country: Japan
facility: Hasegawa Medicine Clinic
city: Hokkaido
country: Japan
facility: Japan Community Health care Organization Hokkaido Hospital
city: Ibaraki
country: Japan
facility: Minami Akatsuka Clinic
city: Kanagawa
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
city: Osaka
country: Japan
facility: Kinugawa Cardiology Clinic
city: Osaka
country: Japan
facility: Kyosokai AMC NISHI-UMEDA Clinic
city: Osaka
country: Japan
facility: Medical corporation Tani clinic
city: Osaka
country: Japan
facility: Shiraiwa medical clinic
city: Saitama
country: Japan
facility: Cosmos medical corporation Aozora total clinic
city: Tokyo
country: Japan
facility: Akasaka Chuou Clinic
city: Tokyo
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
city: Tokyo
country: Japan
facility: Shimokitazawa Tomo Clinic
Study officials:
References: