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New treatment option for Hypercholesterolemia
Official title A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins
ClinicalTrials.gov ID: NCT07634484
What this study is testing
What is Pemafibrate 0.2 mg/day?
Pemafibrate 0.2 mg/day is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypercholesterolemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To investigate the efficacy and safety of Pemafibrate 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who meet all the following criteria shall be eligible for the clinical trial.
- Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent
- Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening...
- Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.
- Patients with the fasting serum TG \< 150 mg/dL on two consecutive occasions at screening
You likely can't join if
- Patients who meet any of the following criteria will be excluded from the clinical trial.
- Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent
- Patients with type 1 diabetes and uncontrolled type 2 diabetes [HbA1c(NGSP) \>= 10.0 % at Screening]
- Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.
- Patients with uncontrolled thyroid disease
- Patients who are undergoing or are scheduled to undergo LDL apheresis
See the full eligibility criteria
- Patients who meet all the following criteria shall be eligible for the clinical trial.
- Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent
- Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.
- Patients who have received stable dietary and/or exercise therapy for at least 12 weeks prior to the first screening assessment.
- Patients with the fasting serum TG \< 150 mg/dL on two consecutive occasions at screening
- Patients who apply any of the following risk category with LDL-C level (direct) based on JAS2022 on two consecutive occasions at screening
- Low risk for primary prevention: LDL-C \>=160 mg/dL
- Intermediate risk for primary prevention: LDL-C \>=140 mg/dL
- High risk for primary prevention: LDL-C\>=120 mg/dL or 100 mg/dL\
- Secondary prevention: LDL-C\>=100 mg/dL
- Familial hypercholesterolemia (heterozygous): LDL-C\>=100 mg/dL
- For patients with diabetes, those with peripheral artery disease (PAD), microvascular complications (retinopathy, nephropathy, neuropathy), or current smoking are included if LDL-C\>=100 mg/dL.
- Patients who meet any of the following criteria will be excluded from the clinical trial.
- Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent
- Patients with type 1 diabetes and uncontrolled type 2 diabetes [HbA1c(NGSP) \>= 10.0 % at Screening]
- Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.
- Patients with uncontrolled thyroid disease
- Patients who are undergoing or are scheduled to undergo LDL apheresis
- Patients with cirrhosis or those with biliary obstruction
- Patients with gallstones
- Patients with familial hypercholesterolemia (homozygotes)
- Patients with impaired renal function (eGFR \< 30 mL/min/1.73 m2 at screening)
- Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg) at screening
- Patients with AST and ALT levels three times or greater than the upper limit of normal at screening
- Patients with CK levels at least three times the upper limit of normal at screening
- Patients with any of the following experiences within 3 months prior to informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke...
- Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization
- Patients with heart failure class III or higher according to NYHA cardiac function classification
- Patients with malignant tumor or those who are judged to have a high risk of recurrence
- Patients with a history of myopathy or rhabdomyolysis due to pemafibrate
- Patients with a history of hypersensitivity due to pemafibrate
- Patients with a history of serious drug allergies (anaphylactic shock, etc.)
- Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women of childbearing potential\ 2 who do not use specific contraceptive methods\ 1
- Patients who have undergone whole blood donation of 400 mL or more within 16 weeks, or 200 mL or more within 4 weeks, or component donation (plasma or platelet donation) within 2 weeks prior to screening.
- Patients with alcoholics or drug addicts
- Patients who participated in other clinical trials of a drug with new active ingredients within 16 weeks or a drug with an approved active ingredients within 12 weeks prior to administration and received an...
- Patients who are considered inappropriate for participation in this study by the investigator, etc
- 1 Acceptable contraceptive methods: Oral hormonal contraceptives (combination pills containing progestin and estrogen), intrauterine devices, intrauterine hormonal delivery systems, abstinence
- 2 Woman of childbearing potential refers to a woman who is physiologically capable of becoming pregnant with a male partner who has not undergone contraception. However, it does not apply if the investigator confirms...
- Patients with hysterectomy or tubal ligation before informed consent
- Post-menopausal women (those who have passed more than 1 year since their last menstrual period without other medical reasons).
The study team makes the final eligibility decision.
Where it's taking place
- Hokkaido, Japan
- Ibaraki, Japan
- Kagawa, Japan
- Kanagawa, Japan
- Osaka, Japan
- Saitama, Japan
- Tokyo, Japan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hokkaido, Japan; Ibaraki, Japan; Kagawa, Japan; Kanagawa, Japan; Osaka, Japan; Saitama, Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.