Clinical trial NCT04289649: K-924 Phase III Confirmatory Study
Official title: A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Kowa Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 293
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
timeFrame: Week 12
Secondary outcomes:
measure: Efficacy : % change or change from baseline in LDL-C (mg / dL)
timeFrame: From baseline upto week 12
measure: Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
timeFrame: From baseline upto week 12
measure: Efficacy : % change or change from baseline in HDL-C (mg / dL)
timeFrame: From baseline upto week 12
measure: Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
timeFrame: From baseline upto week 12
measure: Efficacy : % change or change from baseline in TG (mg / dL)
timeFrame: From baseline upto week 12
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
city: Tokyo
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
Study officials:
References:
citation: 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. doi: 10.5551/jat.64006. Epub 2023 Mar 11.