K-924 Phase III Confirmatory Study

  • STATUS
    Recruiting
  • participants needed
    288
  • sponsor
    Kowa Company, Ltd.
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Updated on 16 February 2024
See if I qualify
cardiovascular disease
atherosclerosis
hypercholesterolemia
primary prevention
pitavastatin

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.

Details
Condition Hypercholesterolemia, Hyperlipidemia
Age 20years - 100years
Treatment K-924 LD, K-924 HD, K-924 LD Placebo, K-924 HD Placebo
Clinical Study IdentifierNCT04289649
SponsorKowa Company, Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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 m 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
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