search
Back to results

K-924 Phase III Confirmatory Study

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
K-924 LD
K-924 HD
K-924 LD Placebo
K-924 HD Placebo
Sponsored by
Kowa Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Corporation Heishinkai OCROM Clinic
  • Medical Corporation Heishinkai OPHAC Hospital
  • Medical Corporation Heishinkai ToCROM Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

K-924 LD

K-924 HD

Pitavastatin 2 mg

Pitavastatin 4 mg

Arm Description

K-924 LD tablet once daily

K-924 HD tablet once daily

K-924 LD Placebo tablet once daily

K-924 HD Placebo tablet once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy : % change or change from baseline in LDL-C (mg / dL)
Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
Efficacy : % change or change from baseline in HDL-C (mg / dL)
Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
Efficacy : % change or change from baseline in TG (mg / dL)

Full Information

First Posted
February 27, 2020
Last Updated
December 22, 2020
Sponsor
Kowa Company, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04289649
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2, 2020 (Actual)
Primary Completion Date
November 21, 2020 (Actual)
Study Completion Date
November 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-924 LD
Arm Type
Experimental
Arm Description
K-924 LD tablet once daily
Arm Title
K-924 HD
Arm Type
Experimental
Arm Description
K-924 HD tablet once daily
Arm Title
Pitavastatin 2 mg
Arm Type
Active Comparator
Arm Description
K-924 LD Placebo tablet once daily
Arm Title
Pitavastatin 4 mg
Arm Type
Active Comparator
Arm Description
K-924 HD Placebo tablet once daily
Intervention Type
Drug
Intervention Name(s)
K-924 LD
Intervention Description
Pitavastatin 2 mg / Ezetimibe 10 mg tables
Intervention Type
Drug
Intervention Name(s)
K-924 HD
Intervention Description
Pitavastatin 4 mg / Ezetimibe 10 mg tables
Intervention Type
Drug
Intervention Name(s)
K-924 LD Placebo
Intervention Description
Pitavastain 2 mg
Intervention Type
Drug
Intervention Name(s)
K-924 HD Placebo
Intervention Description
Pitavastain 4 mg
Primary Outcome Measure Information:
Title
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Efficacy : % change or change from baseline in LDL-C (mg / dL)
Time Frame
From baseline upto week 12
Title
Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
Time Frame
From baseline upto week 12
Title
Efficacy : % change or change from baseline in HDL-C (mg / dL)
Time Frame
From baseline upto week 12
Title
Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
Time Frame
From baseline upto week 12
Title
Efficacy : % change or change from baseline in TG (mg / dL)
Time Frame
From baseline upto week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 12 weeks before 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 Exclusion Criteria: 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 a history of coronary artery disease or patient with familial hypercholesterolemia Patients with malignant tumors or who are judged to have a high possibility of relapse 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) Persons with a history of severe drug allergy (anaphylactic shock, etc.) Patients who need contraindicated drugs during the study period after obtaining consent Patients with TG of 400 mg / dL or more at screening Patients who have LDL apheresis Patients with malabsorption or history, or who have undergone gastrointestinal surgery (excluding appendectomy, hernia treatment, etc.) that may affect absorption. Patients with Alcohol or drug addiction 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 Patients who have received K-924 Patients who judged to be inappropriate by the Investigator or Investigator
Facility Information:
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Osaka
Country
Japan
Facility Name
Medical Corporation Heishinkai OPHAC Hospital
City
Osaka
Country
Japan
Facility Name
Medical Corporation Heishinkai ToCROM Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

K-924 Phase III Confirmatory Study

We'll reach out to this number within 24 hrs