Status:
COMPLETED
K-924 Phase III Long Term Study
Lead Sponsor:
Kowa Company, Ltd.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
March 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04289662
Start Date
March 23 2020
End Date
August 7 2021
Last Update
November 29 2023
Active Locations (13)
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1
Chubu Rosai Hospital
Aichi, Japan
2
Daido Clinic
Aichi, Japan
3
Nakamura Cardiovascular Clinic
Fukuoka, Japan
4
Nippon Kokan Fukuyama Hospital
Hiroshima, Japan