K-924 Phase III Long Term Study

NCT04289662 | Completed Phase 3

• 1 other identifier: K-924-03
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Efficacy: % change from baseline in LDL-C (Friedewald formula) (mg/dL)

  Week 52

Secondary Outcomes (5)

• Efficacy: % change or change from baseline in LDL-C (mg/dL)

  From baseline upto week 52

• Efficacy: % change or change from baseline in non-HDL-C (mg/dL)

  From baseline upto week 52

• Efficacy: % change or change from baseline in HDL-C (mg/dL)

  From baseline upto week 52

• Efficacy: % change or change from baseline in Total Cholesterol (mg/dL)

  From baseline upto week 52

• Efficacy: % change or change from baseline in TG (mg/dL)

  From baseline upto week 52

Study Arms (2)

K-924 LD

EXPERIMENTAL

K-924 LD once daily

Drug: K-924 LD

K-924 HD

EXPERIMENTAL

K-924 HD once daily

Drug: K-924 HD

Interventions

K-924 LD DRUG

Pitavastatin 2 mg / Ezetimibe 10 mg tables

K-924 LD

K-924 HD DRUG

Pitavastatin 4 mg / Ezetimibe 10 mg tables

K-924 HD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hypercholesterolemia had to be age 20 years or older at written informed consent (ICF)
• Patients who have been on a diet and / or exercise regimen more than 4 weeks before the screening
• Patients who have been receiving pitavastatin calcium 2 mg / day or pitavastatin calcium 4 mg / day at least 4 weeks prior to the screening
• 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

You may not qualify if:

• Patients with a history of myopathy or rhabdomyolysis due to pitavastatin or ezetimibe
• Patients with a history of hypersensitivity due to pitavastatin or ezetimibe
• Patients with severe liver damage (Child Pugh Class B or higher) or biliary obstruction
• 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
• Patients whose CK is 3 times or more of the upper limit of the reference value at screening
• Patients whose AST and ALT is 2 times or more of the upper limit of the reference value at screening
• Patients wiht type 1 diabetes or uncontrolled type 2 diabetes as defined HbA1c 8 % or more at screening
• 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
• Patients with eGFR of less than 30 mL / min / 1.73 m² at screening or dialysis
• Patients with heart failure class III or higher according to NYHA cardiac function classification
• Patients with uncontrolled arrhythmia
• Patients with uncontrolled metabolic endocrine disease
• Patients with malignant tumors or who are judged to have a high possibility of relapse
• Patients who developed acute coronary syndrome or stroke within 12 months before obtaining consent
• 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)

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (13)

Chubu Rosai Hospital

Aichi, Japan

Location

Daido Clinic

Aichi, Japan

Location

Nakamura Cardiovascular Clinic

Fukuoka, Japan

Location

Nippon Kokan Fukuyama Hospital

Hiroshima, Japan

Location

Hasegawa Medicine Clinic

Hokkaido, Japan

Location

Miyanomori Memorial Hospital

Hokkaido, Japan

Location

Yuri Ono Clinic

Hokkaido, Japan

Location

Ota General Hospital

Kanagawa, Japan

Location

Suwa Red Cross Hospital

Nagano, Japan

Location

Shiraiwa medical clinic

Osaka, Japan

Location

Minamino Cardiovascular Hospital

Tokyo, Japan

Location

Tokyo Shinagawa Hospital

Tokyo, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, Japan

Location

Related Publications (1)

• Ako J, Yokote K, Tsujita K, Tanigawa R, Kamei R, Suganami H. 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 Atheroscler Thromb. 2024 Mar 1;31(3):288-305. doi: 10.5551/jat.64272. Epub 2023 Sep 16.

  PMID: 37722882 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: March 23, 2020
• Primary Completion: August 7, 2021
• Study Completion: August 7, 2021
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (13)