K-924 Phase III Confirmatory Study

Hypercholesterolemia Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289649
• Other study ID #: K-924-02
• Status: Completed
• Phase: Phase 3
• Start date: April 2, 2020
• Est. completion date: November 21, 2020

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, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: November 21, 2020
• Est. primary completion date: November 21, 2020
• 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 12 weeks before the screening

3. 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

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 a history of coronary artery disease or patient with familial hypercholesterolemia

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

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
• K-924 LD Placebo
Pitavastain 2 mg
• K-924 HD Placebo
Pitavastain 4 mg

Locations

Country	Name	City	State
Japan	Medical Corporation Heishinkai OCROM Clinic	Osaka
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka
Japan	Medical Corporation Heishinkai ToCROM Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Tsujita K, Yokote K, Ako J, Tanigawa R, Tajima S, Suganami H. Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial. J Atheroscler Thromb. 2023 Nov 1;30(11):1580-1600. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)		Week 12
Secondary	Efficacy : % change or change from baseline in LDL-C (mg / dL)		From baseline upto week 12
Secondary	Efficacy : % change or change from baseline in non-HDL-C (mg / dL)		From baseline upto week 12
Secondary	Efficacy : % change or change from baseline in HDL-C (mg / dL)		From baseline upto week 12
Secondary	Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)		From baseline upto week 12
Secondary	Efficacy : % change or change from baseline in TG (mg / dL)		From baseline upto week 12