A Phase III Confirmatory Study of K-877 Extended Release Tablet

Dyslipidemias Clinical Trial

Official title:

A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714151
• Other study ID #: K-877-ER-02
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: September 25, 2021

Study information

• Verified date: June 2024
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: September 25, 2021
• Est. primary completion date: September 25, 2021
• 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 >= 200 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) >= 8.0 % 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 (once daily)
K-877 ER 0.2 mg tablet
• K-877 ER 0.4 mg/day (once daily)
K-877 ER 0.4 mg tablet
• K-877 IR 0.2 mg/day (twice daily)
K-877 IR 0.1 mg tablet

Locations

Country	Name	City	State
Japan	Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic	Kanagawa
Japan	Medical Corporation Heishinkai OCROM Clinic	Osaka
Japan	Dojinkinenkai Meiwa Hospital	Tokyo
Japan	Fukuwa Clinic	Tokyo
Japan	Ikebukuro Metropolitan Clinic	Tokyo
Japan	Medical Corp. Seikoukai New Medical Research System Clinic	Tokyo
Japan	Medical Corporation Asbo Tokyo Asbo Clinic	Tokyo
Japan	Medical Corporation Chiseikai Tokyo Center Clinic	Tokyo
Japan	Medical Corporation Heishinkai ToCROM Clinic	Tokyo
Japan	Medical Corporation Yuhokai Miho Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy : % change from baseline in fasting serum TG (mg/dL)		4, 8, and 12 week after administration
Secondary	Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)		4, 8, and 12 week after administration
Secondary	Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)		4, 8, and 12 week after administration
Secondary	Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)		4, 8, and 12 week after administration
Secondary	Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)		4, 8, and 12 week after administration