Dyslipidemia
Conditions
Interventions
investigational material(s)
Generic name etc : pemafibrate CR
INN of investigational material : Pemafibrate
Therapeutic category code : 3-- Agents affecting metabolism
Dosage and Administration for In
Sponsors
Kowa Company, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF) (2) Men and postmenopausal women. (3) Patients who have received dietary or exercise guidance from 12 weeks prior to Screening. (4) Patients who have clinical laboratory records with fasting serum TG => 150 mg/dL(or => 200 mg/dL if not fasting)within 6 months before written informed consent. (5) Patients with a fasting serum TG => 150 mg/dL at Screening.
Exclusion criteria
Exclusion criteria: (1) Patients with a fasting serum TG => 500 mg/dL at Screening (2) Patients who require administration of prohibited drugs during the clinical trial period after written informed consent (3) Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc) (4) Patients with uncontrolled thyroid disease (5) Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) => 8.0% at Screening (6) Persons with uncontrolled hypertension (SBP => 160 mmHg or DBP => 100 mmHg) (7) Patients with an AST or ALT three times the upper limit at Screening (8) Patients with cirrhosis or those with biliary obstruction (9) Patients with malignant tumor or those who are judged to have a high risk of recurrence (10) Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening (11) Patients with a history of serious drug allergies (anaphylactic shock, etc.) (12) Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety (13) Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks (14) Patients who have been determined inappropriate by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy % change from baseline in fasting serum TG(mg/dL) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy % change from baseline in fasting HDL-C levels(mg/dL) % change from baseline in fasting LDL-C levels(mg/dL) % change from baseline in fasting non-HDL-C levels(mg/dL) % change from baseline in fasting Total Cholesterol levels(mg/dL) | — |
Countries
Japan
Outcome results
None listed