K-924 Phase III Confirmatory Study

November 26, 2023 updated by: Kowa Company, Ltd.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

293

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Osaka, Japan
        • Medical Corporation Heishinkai OCROM Clinic
      • Osaka, Japan
        • Medical Corporation Heishinkai OPHAC Hospital
      • Tokyo, Japan
        • Medical Corporation Heishinkai ToCROM Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: K-924 LD
K-924 LD tablet once daily
Pitavastatin 2 mg / Ezetimibe 10 mg tables
Experimental: K-924 HD
K-924 HD tablet once daily
Pitavastatin 4 mg / Ezetimibe 10 mg tables
Active Comparator: Pitavastatin 2 mg
K-924 LD Placebo tablet once daily
Pitavastain 2 mg
Active Comparator: Pitavastatin 4 mg
K-924 HD Placebo tablet once daily
Pitavastain 4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy : % change or change from baseline in LDL-C (mg / dL)
Time Frame: From baseline upto week 12
From baseline upto week 12
Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
Time Frame: From baseline upto week 12
From baseline upto week 12
Efficacy : % change or change from baseline in HDL-C (mg / dL)
Time Frame: From baseline upto week 12
From baseline upto week 12
Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
Time Frame: From baseline upto week 12
From baseline upto week 12
Efficacy : % change or change from baseline in TG (mg / dL)
Time Frame: From baseline upto week 12
From baseline upto week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2020

Primary Completion (Actual)

November 21, 2020

Study Completion (Actual)

November 21, 2020

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • K-924-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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