A Phase III Long Term Study of K-877 Extended Release Tablet

Dyslipidemias Clinical Trial

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-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716595
• Other study ID #: K-877-ER-03
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2022
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 29, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• K-877 ER 0.2 mg/day morning administration (once daily)
K-877 ER 0.2 mg tablet
• K-877 ER 0.2 mg/day evening administration (once daily)
K-877 ER 0.2 mg tablet

Locations

Country	Name	City	State
Japan	Saiseikai Futsukaichi Hospital	Fukuoka
Japan	National Hospital Organization Takasaki General Medical Center	Gunma
Japan	Hasegawa Medicine Clinic	Hokkaido
Japan	Japan Community Health care Organization Hokkaido Hospital	Hokkaido
Japan	Minami Akatsuka Clinic	Ibaraki
Japan	Saiseikai Yokohamashi Nanbu Hospital	Kanagawa
Japan	Kinugawa Cardiology Clinic	Osaka
Japan	Kyosokai AMC NISHI-UMEDA Clinic	Osaka
Japan	Medical corporation Tani clinic	Osaka
Japan	Shiraiwa medical clinic	Osaka
Japan	Cosmos medical corporation Aozora total clinic	Saitama
Japan	Akasaka Chuou Clinic	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Tokyo
Japan	Shimokitazawa Tomo Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Final evaluation (Week 52 or at discontinuation) and immediately before it
Secondary	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		Final evaluation (Week 52 or at discontinuation) and immediately before it
Secondary	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		Final evaluation (Week 52 or at discontinuation) and immediately before it
Secondary	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		Final evaluation (Week 52 or at discontinuation) and immediately before it
Secondary	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		Final evaluation (Week 52 or at discontinuation) and immediately before it