HypercholesterolemiaPhase 3NCT04289649
K-924 Phase III Confirmatory Study
A Phase 3 study testing K-924 LD and K-924 HD in people with Hypercholesterolemia, run by Kowa Company, Ltd. at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- K-924 LD and K-924 HD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 3 sitesJapan
- Study dates
- 2 Apr 2020to 21 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Medical Corporation Heishinkai OCROM Clinic
Osaka
Medical Corporation Heishinkai OPHAC Hospital
Osaka
Medical Corporation Heishinkai ToCROM Clinic
Tokyo
About this study
Official title: 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.
- Conditions
- Hypercholesterolemia
- Being tested
- K-924 LD, K-924 HD, K-924 LD Placebo, K-924 HD Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-924 LDDrug
Pitavastatin 2 mg / Ezetimibe 10 mg tables
K-924 HDDrug
Pitavastatin 4 mg / Ezetimibe 10 mg tables
K-924 LD PlaceboDrug
Pitavastain 2 mg
K-924 HD PlaceboDrug
Pitavastain 4 mg
| Study group | Role | What they receive |
|---|---|---|
| K-924 LD | Experimental | K-924 LD tablet once daily Receives: Drug: K-924 LD |
| K-924 HD | Experimental | K-924 HD tablet once daily Receives: Drug: K-924 HD |
| Pitavastatin 2 mg | Active comparator | K-924 LD Placebo tablet once daily Receives: Drug: K-924 LD Placebo |
| Pitavastatin 4 mg | Active comparator | K-924 HD Placebo tablet once daily Receives: Drug: K-924 HD Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
Measured: Week 12
Secondary outcomes (5)
Efficacy : % change or change from baseline in LDL-C (mg / dL)
Measured: From baseline upto week 12
Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
Measured: From baseline upto week 12
Efficacy : % change or change from baseline in HDL-C (mg / dL)
Measured: From baseline upto week 12
Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
Measured: From baseline upto week 12
Efficacy : % change or change from baseline in TG (mg / dL)
Measured: From baseline upto week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start2 Apr 2020
- Primary completion21 Nov 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289649
- Sponsor's protocol ID
- K-924-02
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36908150
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Clinial Trial to Evaluate the Efficacy and Safety of K-924 in Patienta With Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT04289649
- Acronym / sponsor ID
- K-924-02
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Kowa Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| K-924 LD | Experimental | Drug: K-924 LDK-924 LD tablet once daily |
| K-924 HD | Experimental | Drug: K-924 HDK-924 HD tablet once daily |
| Pitavastatin 2 mg | Active comparator | Drug: K-924 LD PlaceboK-924 LD Placebo tablet once daily |
| Pitavastatin 4 mg | Active comparator | Drug: K-924 HD PlaceboK-924 HD Placebo tablet once daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-924 LDPitavastatin 2 mg / Ezetimibe 10 mg tables | Drug | K-924 LD |
| K-924 HDPitavastatin 4 mg / Ezetimibe 10 mg tables | Drug | K-924 HD |
| K-924 LD PlaceboPitavastain 2 mg | Drug | Pitavastatin 2 mg |
| K-924 HD PlaceboPitavastain 4 mg | Drug | Pitavastatin 4 mg |
Primary outcome
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL)
Time frame: Week 12
5 secondary outcomes
Efficacy : % change or change from baseline in LDL-C (mg / dL)
Time frame: From baseline upto week 12
Efficacy : % change or change from baseline in non-HDL-C (mg / dL)
Time frame: From baseline upto week 12
Efficacy : % change or change from baseline in HDL-C (mg / dL)
Time frame: From baseline upto week 12
Efficacy : % change or change from baseline in Total Cholesterol (mg / dL)
Time frame: From baseline upto week 12
Efficacy : % change or change from baseline in TG (mg / dL)
Time frame: From baseline upto week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Results publication: PubMed 36908150Tsujita 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing K-924 LD and K-924 HD in people with Hypercholesterolemia, run by Kowa Company, Ltd. at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : % change from baseline in LDL-C (Friedewald formula) (mg / dL) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.