K-924 Phase III Long Term Study

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Open-label Study to Evaluate 52 Weeks Long Term Efficacy and Safety of K-924 in Patients With Hypercholesterolemia Who Were Treated With Pitavastatin 2 mg or 4 mg.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289662
• Other study ID #: K-924-03
• Status: Completed
• Phase: Phase 3
• Start date: March 23, 2020
• Est. completion date: August 7, 2021

Study information

• Verified date: November 2023
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multicenter, Open-label Study to Evaluate 52 weeks long term Efficacy and Safety of K-924 in Patients with hypercholesterolemia who were treated with pitavastatin 2 mg or 4 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 7, 2021
• Est. primary completion date: August 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with hypercholesterolemia had to be age 20 years or older at written informed consent (ICF)

2. Patients who have been on a diet and / or exercise regimen more than 4 weeks before the screening

3. Patients who have been receiving pitavastatin calcium 2 mg / day or pitavastatin calcium 4 mg / day at least 4 weeks prior to the screening

4. Those whose LDL-C (Friedewald formula) at the screening any of the following in the category classification based on Japan Atherosclerosis Society guidelines for prevention Atherosclerotic Cardiovascular Disease 2017

• Low risk of primary prevention : LDL-C => 160 mg/dL

• Medium risk of primary prevention : LDL-C => 140 mg/dL

• High risk of primary prevention : LDL-C => 120 mg/dL

• Secondary prevention patients with a history of coronary artery disease : LDL-C => 100 mg/dL

• Secondary prevention patients with familial hypercholesterolemia or acute coronary syndrome, or diabetes with other high-risk conditions : LDL-C => 70 mg/dL

Exclusion Criteria:

1. Patients with a history of myopathy or rhabdomyolysis due to pitavastatin or ezetimibe

2. Patients with a history of hypersensitivity due to pitavastatin or ezetimibe

3. Patients with severe liver damage (Child Pugh Class B or higher) or biliary obstruction

4. 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

5. Patients whose CK is 3 times or more of the upper limit of the reference value at screening

6. Patients whose AST and ALT is 2 times or more of the upper limit of the reference value at screening

7. Patients wiht type 1 diabetes or uncontrolled type 2 diabetes as defined HbA1c 8 % or more at screening

8. Patients with uncontrolled hypertension as defined systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more at screening

9. Patients with eGFR of less than 30 mL / min / 1.73 m² at screening or dialysis

10. Patients with heart failure class III or higher according to NYHA cardiac function classification

11. Patients with uncontrolled arrhythmia

12. Patients with uncontrolled metabolic endocrine disease

13. Patients with malignant tumors or who are judged to have a high possibility of relapse

14. Patients who developed acute coronary syndrome or stroke within 12 months before obtaining consent

15. Patients who have collected 200 mL or more within 4 weeks before screening, 400 mL or more of blood within 12 weeks for males or 16 weeks for females, or within 2 weeks for (Plasma component / platelet component)

16. Persons with a history of severe drug allergy (anaphylactic shock, etc.)

17. Patients who need contraindicated drugs during the study period after obtaining consent

18. Patients with TG of 400 mg / dL or more at screening

19. Patients who have LDL apheresis

20. Patients with malabsorption or history, or who have undergone gastrointestinal surgery (excluding appendectomy, hernia treatment, etc.) that may affect absorption.

21. Patients with Alcohol or drug addiction

22. Patients who participate in other clinical trials within 16 weeks prior to study drug administration and who are administered non-placebo investigational drugs, or who participate in other clinical trials concurrently with this study

23. Patients who have received K-924

24. Patients who judged to be inappropriate by the Investigator or Investigator

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• K-924 LD
Pitavastatin 2 mg / Ezetimibe 10 mg tables
• K-924 HD
Pitavastatin 4 mg / Ezetimibe 10 mg tables

Locations

Country	Name	City	State
Japan	Chubu Rosai Hospital	Aichi
Japan	Daido Clinic	Aichi
Japan	Nakamura Cardiovascular Clinic	Fukuoka
Japan	Nippon Kokan Fukuyama Hospital	Hiroshima
Japan	Hasegawa Medicine Clinic	Hokkaido
Japan	Miyanomori Memorial Hospital	Hokkaido
Japan	Yuri Ono Clinic	Hokkaido
Japan	Ota General Hospital	Kanagawa
Japan	Suwa Red Cross Hospital	Nagano
Japan	Shiraiwa medical clinic	Osaka
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	Tokyo Shinagawa Hospital	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)

Ako J, Yokote K, Tsujita K, Tanigawa R, Kamei R, Suganami H; K-Clinical Study Group. Long-term Efficacy and Safety of K-924 Pitavastatin/Ezetimibe Fixed-dose Combination in Patients with Hypercholesterolemia: A Phase III, Multi-center, Open-label Trial. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: % change from baseline in LDL-C (Friedewald formula) (mg/dL)		Week 52
Secondary	Efficacy: % change or change from baseline in LDL-C (mg/dL)		From baseline upto week 52
Secondary	Efficacy: % change or change from baseline in non-HDL-C (mg/dL)		From baseline upto week 52
Secondary	Efficacy: % change or change from baseline in HDL-C (mg/dL)		From baseline upto week 52
Secondary	Efficacy: % change or change from baseline in Total Cholesterol (mg/dL)		From baseline upto week 52
Secondary	Efficacy: % change or change from baseline in TG (mg/dL)		From baseline upto week 52