K-924 Phase III Confirmatory Study

NCT04289649 | Completed Phase 3

• 1 other identifier: K-924-02
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

  Week 12

Secondary Outcomes (5)

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

  From baseline upto week 12

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

  From baseline upto week 12

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

  From baseline upto week 12

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

  From baseline upto week 12

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

  From baseline upto week 12

Study Arms (4)

K-924 LD

EXPERIMENTAL

K-924 LD tablet once daily

Drug: K-924 LD

K-924 HD

EXPERIMENTAL

K-924 HD tablet once daily

Drug: K-924 HD

Pitavastatin 2 mg

ACTIVE COMPARATOR

K-924 LD Placebo tablet once daily

Drug: K-924 LD Placebo

Pitavastatin 4 mg

ACTIVE COMPARATOR

K-924 HD Placebo tablet once daily

Drug: K-924 HD Placebo

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

K-924 LD Placebo DRUG

Pitavastain 2 mg

Pitavastatin 2 mg

K-924 HD Placebo DRUG

Pitavastain 4 mg

Pitavastatin 4 mg

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 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

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 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)

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (3)

Medical Corporation Heishinkai OCROM Clinic

Osaka, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Tokyo, Japan

Location

Related Publications (1)

• Tsujita K, Yokote K, Ako J, Tanigawa R, Tajima S, Suganami H. Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial. J Atheroscler Thromb. 2023 Nov 1;30(11):1580-1600. doi: 10.5551/jat.64006. Epub 2023 Mar 11.

  PMID: 36908150 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: February 28, 2020
• Study Start: April 2, 2020
• Primary Completion: November 21, 2020
• Study Completion: November 21, 2020
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)